Gauge Bl Pointer, Angled 52565-10
by Brainlab SE
Gauge Bl Pointer, Angled 52565-10 (41784B) is a Class II device made by Brainlab SE, cleared under FDA 510(k) K102990 on 4 Apr 2011 and listed in FDA GUDID since 2 Jul 2020 (UDI-DI 04056481095277), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number04056481095277 | Date2 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102990 | Date4 Apr 2011 | StatusActive |
Official records
- AccessGUDID record 04056481095277
- FDA 510(k) database K102990
Across registries
- FDA 510(k) K102990 decided 4 Apr 2011 Active
- FDA GUDID UDI-DI 04056481095277 listed 2 Jul 2020 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 04056481095277
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gauge Bl Pointer, Angled
- Generic name
- Robotic surgical navigation system
- Model / Ref / Catalog
- 52565-10, 41784B
- Primary DI / UDI-DI
- 04056481095277
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Robotic surgical navigation system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization