Clearlens 53236
Clearlens 53236 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K102990 on 4 Apr 2011 and listed in FDA GUDID since 28 May 2021 (UDI-DI 00885556805008), 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 | Number00885556805008 | Date28 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102990 | Date4 Apr 2011 | StatusActive |
Official records
- AccessGUDID record 00885556805008
- FDA 510(k) database K102990
Across registries
- FDA 510(k) K102990 decided 4 Apr 2011 Active
- FDA GUDID UDI-DI 00885556805008 listed 28 May 2021 Listed
Recalls
-
- Terminated Z-0959-2017
Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing
Timeline
- Cleared FDA 510(k) K102990
- Recall initiated FDA recalls Z-0959-2017
- Listed FDA GUDID 00885556805008
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Clearlens
- Generic name
- Robotic surgical navigation system
- Model / Ref / Catalog
- 53236
- Primary DI / UDI-DI
- 00885556805008
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Robotic surgical navigation system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Robotic surgical navigation system.