Identity
- Trade Name
- Clarus Flexible Fiberoptic Endoscope FDA UDI
- Generic Name
- Flexible fibreoptic epiduroscope FDA UDI
- Device Name
- Endoscope, Flexible Fiberoptic FDA UDI
- Model / Reference
- 3000C FDA UDI
- Description
- Endoscope, Flexible Fiberoptic FDA UDI
Identifiers
- Catalog Number
- 3000C FDA UDI
- Primary DI / UDI-DI
- B0673000C0 FDA UDI
- 510(k) Number
- K942249 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Flexible fibreoptic epiduroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1480 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
Yes
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
No
FDA UDI
Category: Flexible fibreoptic epiduroscope
Clarus Flexible Fiberoptic Endoscope by Clarus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic epiduroscope.
- SPINAUT-S — IMEDICOM CO., LTD. · Class II
- SPINAUT-S — IMEDICOM CO., LTD. · Class II
- SPINAUT-S — IMEDICOM CO., LTD. · Class II
Cleared under the same submission
K942249 also covers:
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
- Clarus Medical, Llc
Sources (1)
- FDA UDI 16aa7c89-2f21-4ebf-bd5f-6a6cf59a18db 36 fields · synced Jun 1, 2026