{"id":3326,"date":"2025-12-24T20:02:34","date_gmt":"2025-12-24T20:02:34","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=3326"},"modified":"2025-12-24T20:02:35","modified_gmt":"2025-12-24T20:02:35","slug":"intragastric-balloons-classification-and-grouping-in-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/intragastric-balloons-classification-and-grouping-in-colombia\/","title":{"rendered":"Intragastric Balloons: Classification and Grouping in Colombia."},"content":{"rendered":"<p><span data-contrast=\"auto\">Intragastric balloons are non-surgical medical devices used in weight control therapies. Designed for temporary placement in the stomach, they help reduce food intake and promote satiety, supporting weight loss in individuals with\u00a0overweight\u00a0or obesity. This article outlines the structural features, clinical applications, and regulatory classification of intragastric balloons within the\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/co\/guides\/ultimate-guide-for-regulatory-affairs-in-colombia\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Colombian healthcare system.<\/span><\/a><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Structure and Function of Intragastric Balloons<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">An intragastric balloon system typically consists of a soft, expandable silicone balloon connected to an inflation catheter. The balloon is inserted endoscopically and inflated with sterile saline or air to occupy space in the stomach. This induces a feeling of fullness and helps reduce\u00a0caloric\u00a0intake.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Some advanced models feature an adjustable inflation mechanism, allowing volume modifications\u00a0post-placement without device removal. This adjustability supports personalized treatment plans and enhances patient tolerance throughout the therapy duration.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Key\u00a0components\u00a0may\u00a0include:<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Silicone Balloon: Biocompatible and flexible, with a typical diameter around\u00a090 mm.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Inflation Catheter: Non-collapsible and permanently attached, enabling initial deployment and\u00a0subsequent\u00a0volume adjustments.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Extension Tubing:\u00a0polymer-based, with\u00a0luer-lock connectors for secure inflation control.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Insertion Accessories<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">Inflation Syringe: Standard\u00a0luer-lock syringe for balloon inflation and deflation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Types of Intragastric Balloons<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Intragastric balloons differ based on:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"10\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Inflation Method<\/span><\/b><span data-contrast=\"auto\">:\u00a0<\/span><i><span data-contrast=\"auto\">Saline-filled vs. air-filled<\/span><\/i><span data-contrast=\"auto\">.<\/span><br \/>\n<span data-contrast=\"auto\">Saline-filled systems are used in approximately 80% of procedures due to their added safety benefits. If a leak occurs, the patient\u2019s urine may change color, serving as an early warning sign. In contrast, air-filled systems do not provide any visible\u00a0indication\u00a0if the balloon deflates.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"10\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Adjustability<\/span><\/b><span data-contrast=\"auto\">:\u00a0<\/span><i><span data-contrast=\"auto\">Fixed-volume vs. adjustable-volume<\/span><\/i><span data-contrast=\"auto\">.<\/span><br \/>\n<span data-contrast=\"auto\">Adjustable-volume systems offer greater flexibility and allow for patient-specific customization, which can lead to better clinical outcomes and fewer adverse events.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">How Are\u00a0Intragastric Balloons\u202f<\/span><\/b><a href=\"https:\/\/veraqueconsulting.com\/co\/guides\/device-classification-and-device-grouping-colombia\/\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Classified and Grouped in\u00a0Colombia<\/span><\/b><\/a><b><span data-contrast=\"auto\">?\u202f<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In Colombia, intragastric balloons are regulated under\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/co\/guides\/ultimate-guide-for-regulatory-affairs-in-colombia\/#ministry\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Decree 4725 of 2005.<\/span><\/a><span data-contrast=\"auto\">\u00a0According to this regulation, intragastric balloons are classified as\u00a0<\/span><b><span data-contrast=\"auto\">Class IIb<\/span><\/b><span data-contrast=\"auto\">\u00a0medical devices<\/span><span data-contrast=\"auto\">, due to their\u00a0<\/span><span data-contrast=\"auto\">invasive nature\u00a0and\u00a0prolonged use<\/span><span data-contrast=\"auto\">\u00a0within the human body.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"auto\">Grouping Strategy for Registration:\u202f<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">According to\u00a0INVIMA\u00a0guidelines, devices with the same intended use, manufacturer, and distinctive denomination may be grouped under a single sanitary registration.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For intragastric balloons, grouping is\u00a0permitted\u00a0when the models:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Are packaged by the manufacturer together with implantation or filling accessories in the same package or sterilization tray.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Include components that are not considered standalone medical devices.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">If any accessory (e.g., a syringe) is packaged separately and selected by the surgeon, it must be registered independently.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><\/h3>\n<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Intragastric balloons offer a structured, non-surgical intervention for obesity management, supporting patient adherence through minimally invasive placement and in some cases adjustable volume features. Stakeholders in the medical device industry must remain informed of Colombia\u2019s regulatory frameworks to\u00a0facilitate\u00a0proper device registration, clinical integration, and post-market surveillance.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span class=\"TextRun SCXW193334339 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW193334339 BCX0\">Need help evaluating your medical device for\u00a0<\/span><span class=\"NormalTextRun SCXW193334339 BCX0\">Colombi<\/span><span class=\"NormalTextRun SCXW193334339 BCX0\">an sanitary registration?\u00a0<\/span><\/span><span class=\"LineBreakBlob BlobObject DragDrop SCXW193334339 BCX0\"><span class=\"SCXW193334339 BCX0\">\u00a0<\/span><br class=\"SCXW193334339 BCX0\" \/><\/span><span class=\"TextRun SCXW193334339 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW193334339 BCX0\">Contact<\/span><span class=\"NormalTextRun SCXW193334339 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW193334339 BCX0\">\u202f<\/span><\/span><a class=\"Hyperlink SCXW193334339 BCX0\" href=\"mailto:contact@veraqueconsulting.com\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW193334339 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW193334339 BCX0\" data-ccp-charstyle=\"Hyperlink\">Veraque<\/span><\/span><\/a><span class=\"TextRun SCXW193334339 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW193334339 BCX0\">\u202ffor expert regulatory guidance.\u202f<\/span><\/span><span class=\"EOP SCXW193334339 BCX0\" data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Intragastric balloons are non-surgical medical devices used in weight control therapies. Designed for temporary placement in the stomach, they help reduce food intake and promote satiety, supporting weight loss in individuals with\u00a0overweight\u00a0or obesity. This article outlines the structural features, clinical applications, and regulatory classification of intragastric balloons within the\u00a0Colombian healthcare system.\u00a0 \u00a0 \u00a0 Structure and [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3327,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,396],"tags":[],"class_list":["post-3326","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-colombia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Intragastric Balloons: Classification and Grouping in Colombia. - Veraque Colombia<\/title>\n<meta name=\"description\" content=\"Why intragastric balloons are Class IIb under INVIMA: device types, classification and grouping strategy in 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