Identity
- Trade Name
- Endoscopic camera FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Model / Reference
- HDC907 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056702002978 FDA UDI
- 510(k) Number
- K014158 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope video camera
Endoscopic camera by W.O.M. World of Medicine GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope video camera.
- ZEOS — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
- ILO — ILO electronic GmbH · Class I
- VS3-IR — VISIONSENSE LTD. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- JEDMED — JEDMED Instrument Company · Class I
- Arthrex® — Arthrex, Inc. · Class II
- JEDMED — JEDMED Instrument Company · Class I
- JEDMED — JEDMED Instrument Company · Class I
Cleared under the same submission
K014158 also covers:
- HD 1200 — Smith & Nephew, Inc.
- HD 1200 — Smith & Nephew, Inc.
- HD 1200 — Smith & Nephew, Inc.
- HD 1200 — Smith & Nephew, Inc.
- HD 1200 — Smith & Nephew, Inc.
- Endoscopic camera — W.O.M. World of Medicine GmbH
- Endoscopic camera — W.O.M. World of Medicine GmbH
- Endoscopic camera — W.O.M. World of Medicine GmbH
- Endoscopic camera — W.O.M. World of Medicine GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- W.O.M. World of Medicine GmbH
Sources (1)
- FDA UDI cf3b7d13-dfec-47ff-b03b-7873a7a2502f 33 fields · synced May 30, 2026