Naviaid Balloon Guided Colonoscopy (BGC) Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102616 FDA 510(k)
- FDA Product Code
- FDF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Naviaid Balloon Guided Colonoscopy (BGC) Device is a disposable balloon system used to facilitate advancement of a standard endoscope into the large and/or small intestine. It is designed to help overcome conventional limitations during colonoscopy procedures by providing a method for navigating through difficult areas of the colon.
The device is supplied as a single-use disposable system and requires an Air Supply Unit for inflating and deflating the balloon. It is authorized under FDA 510K clearance with product code FDF and is classified as a Class II device for colonoscope and accessories in gastroenterology and urology. The device can be introduced through the working channel of an endoscope during procedures without the need for pre-mounting.
Frequently asked questions
What is the Naviaid Balloon Guided Colonoscopy Device used for?
The Naviaid BGC Device is a disposable balloon system designed to help overcome conventional limitations during colonoscopy procedures by providing a method for navigating through difficult areas of the large and/or small intestine.
How is the Naviaid BGC Device supplied and used?
The device is supplied as a single-use disposable system and requires an Air Supply Unit for inflating and deflating the balloon. It can be introduced through the working channel of an endoscope during procedures without the need for pre-mounting.
What is the regulatory classification of the Naviaid BGC Device?
The device is authorized under FDA 510K clearance with product code FDF and is classified as a Class II device for colonoscope and accessories in gastroenterology and urology.
Is the Naviaid BGC Device reusable or single-use?
The Naviaid BGC Device is supplied as a single-use disposable system, meaning it should be discarded after a single procedure to ensure patient safety and device performance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Naviaid Balloon Guided Colonoscopy (Bgc) Device, NaviAid™ AB - Smart Medical Systems, NaviAid™ AB - Smart Medical Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102616 | Class II | Active |
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Manufacturer
- Manufacturer
- Smart Medical Systems Ltd
- FDA Applicant
- Smart Medical Systems , Ltd.
Sources (1)
- FDA 510(k) K102616 24 fields · synced Oct 1, 2026