Endoscopic camera HDC907
by W.O.M. World of Medicine GmbH 2 variants
Endoscopic camera HDC907 is a Class II device made by W.O.M. World of Medicine GmbH, cleared under FDA 510(k) K014158 on 14 Mar 2002 and listed in FDA GUDID since 9 Aug 2016 (UDI-DI 04056702002978), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04056702002978 | Date9 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK014158 | Date14 Mar 2002 | StatusActive |
Official records
- AccessGUDID record 04056702002978
- FDA 510(k) database K014158
Across registries
- FDA 510(k) K014158 decided 14 Mar 2002 Active
- FDA GUDID UDI-DI 04056702002978 listed 9 Aug 2016 Listed
Recalls
-
- Terminated Z-0082-2012
HD1200 camera heads may cause image issues
Timeline
- Cleared FDA 510(k) K014158
- Recall initiated FDA recalls Z-0082-2012
- Listed FDA GUDID 04056702002978
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Endoscopic camera
- Generic name
- Endoscope video camera
- Model / reference
- HDC907
- Primary DI / UDI-DI
- 04056702002978
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Endoscope video camera
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution