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ClearLens Pointer Handle - Knee 53237A

by Brainlab SE

ClearLens Pointer Handle - Knee 53237A is a Class II device made by Brainlab SE, cleared under FDA 510(k) K220652 on 3 Jun 2022 (1 earlier submission) and listed in FDA GUDID since 6 Aug 2019 (UDI-DI 04056481138721), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220652 Date3 Jun 2022DecidedStatusActive
United StatesGUDID listing Number04056481138721 UDI-DI Date6 Aug 2019ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220652 decided 3 Jun 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04056481138721 listed 6 Aug 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-0959-2017 FDA Class II initiated 27 Oct 2016

    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

4 dated events

  1. Cleared FDA 510(k) K102990
  2. Recall initiated FDA recalls Z-0959-2017
  3. Listed FDA GUDID 04056481138721
  4. Cleared FDA 510(k) K220652

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ClearLens Pointer Handle - Knee
Generic name
Robotic surgical navigation system
Model / Ref / Catalog
53237A
Primary DI / UDI-DI
04056481138721
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

Related devices

Cleared under the same submission (K102990)

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Sterilise before use
  • Serial number
Other properties (13, all answered No)