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Zimmer A.T.S. 4000TS Automatic Tourniquet System

by Zimmer, Inc.

510(k) K123553

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK123553 Date9 Aug 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0612-2018 FDA Class II initiated 27 Jul 2017

    Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

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  • Withdrawn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
KCY
Device Class
Class I
Regulation
21 CFR Part 878.5910
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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