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TRUMPF SURGICAL LIGHTS - 301

by Trumpf Medical Systems, Inc.

510(k) K011693

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011693 Date13 Jun 2001ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2355-2015 FDA Class II initiated 27 Jul 2015

    Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

    • Terminated Z-0484-2014 FDA Class II initiated 19 Feb 2013

    Possible fatigue failure of the plastic joint may occur after an average use of seven years.

    • Terminated Z-0077-2013 FDA Class II initiated 19 Sep 2012

    Incidents regarding fractures of the front joint of the spring arm have been reported.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FSY
Models / Variants
301
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent