Identifiers
- 510(k) Number
- K202469 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 G-Eye System is a flexible/rigid colonoscope and accessories designed for gastrointestinal procedures. It features a reusable balloon integrated into the bending section of a standard colonoscope, which aids in flattening colonic folds and stabilizing the optical field during insertion and examination.
The device is supplied as a reusable system with a reprocessable balloon component, intended for use in gastroenterology and urology settings. It requires sterile processing between uses and is classified as a Class II medical device under FDA regulations (21 CFR 876.1500). The system includes multiple accessory parts referenced by FEI numbers, all cleared under the traditional 510(k) pathway as substantially equivalent to predicate devices.
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: G-EYE® - Smart Medical Systems, G-EYE® - Smart Medical Systems, K202469 FDA 510(k) - G-EYE System | Smart Medical Systems , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202469 | Class II | Active |
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Manufacturer
- Manufacturer
- Smart Medical Systems Ltd
- FDA Applicant
- Smart Medical Systems , Ltd.
Sources (1)
- FDA 510(k) K202469 24 fields · synced Sep 19, 2026