Trokamed GmbH Endoscopes and Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060233 FDA 510(k)
- FDA Product Code
- GCJ 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)
This device is a collection of endoscopes and accessories manufactured by Trokamed GmbH. It is identified by the device name Trokamed GmbH Endoscopes and Accessories and associated with product code GCJ.
The device received FDA 510(k) clearance under K060233 on July 19, 2006, and was found substantially equivalent. It was reviewed by the Gastroenterology and Urology advisory committee and is manufactured at Kleine Breite 17, Geisingen, Germany, postal code 78187.
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: Trokamed, TROKAMED GmbH | Präzision in MedTech, Trokamed GmbH - blueendo GmbH international - Medical Products Supplies ..., TROKAMED GmbH Products - medical-xprt.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060233 | Class II | Active |
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Manufacturer
- Manufacturer
- TROKAMED GmbH
Sources (1)
- FDA 510(k) K060233 24 fields · synced Sep 26, 2026