ChannelScope 2233-005
ChannelScope 2233-005 is a Class II device made by Clarus Medical, LLC, cleared under FDA 510(k) K945633 on 19 Sep 1995 and listed in FDA GUDID since 10 Jul 2020 (UDI-DI 00810004820654), active as of 22 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 | Number00810004820654 | Date10 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK945633 | Date19 Sep 1995 | StatusActive |
Official records
- AccessGUDID record 00810004820654
- FDA 510(k) database K945633
Across registries
- FDA 510(k) K945633 decided 19 Sep 1995 Active
- FDA GUDID UDI-DI 00810004820654 listed 10 Jul 2020 Listed
Recalls
-
- Terminated Z-0049-04
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Timeline
- Cleared FDA 510(k) K945633
- Recall initiated FDA recalls Z-0049-04
- Listed FDA GUDID 00810004820654
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ChannelScope
- Generic name
- Rigid optical intracranial/spinal endoscope, single-use
- Model / Ref / Catalog
- 2233-005
- Primary DI / UDI-DI
- 00810004820654
- 510(k) Number
- FDA product code
- GWG
- GMDN term
- Rigid optical intracranial/spinal endoscope, single-use
- Device class
- Class II
- Regulation number
- 882.1480
- GUDID distribution status
- In Commercial Distribution