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Auto Suture(R) Endoscopic Clamp

by United States Surgical, A Division of Tyco Healthc

510(k) K903205

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 NumberK903205 Date11 Oct 1990ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1211-2019 FDA Class II initiated 13 Mar 2019
    • Terminated Z-1212-2019 FDA Class II initiated 13 Mar 2019
    • Terminated Z-1213-2019 FDA Class II initiated 13 Mar 2019

    Sterilization method used was not consistent with the labeling and the approved sterilization method

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  • Withdrawn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
HDA
Device Class
Class II
Regulation
21 CFR Part 884.4400
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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