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Auto Suture Modified Vcs Clip Applier

by United States Surgical, A Division of Tyco Healthc

510(k) K962043

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 NumberK962043 Date23 Sep 1996ClearedStatusActive

Recalls

7 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-2285-2016 FDA Class II initiated 22 Jun 2016
    • Terminated Z-2289-2016 FDA Class II initiated 22 Jun 2016
    • Terminated Z-2284-2016 FDA Class II initiated 22 Jun 2016
    • Terminated Z-2286-2016 FDA Class II initiated 22 Jun 2016
    • Terminated Z-2287-2016 FDA Class II initiated 22 Jun 2016
    • Terminated Z-2288-2016 FDA Class II initiated 22 Jun 2016

    US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

    • Terminated Z-2283-2016 FDA Class II initiated 22 Jun 2016

    US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use

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  • Withdrawn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
FZP
Device Class
Class II
Regulation
21 CFR Part 878.4300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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