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Auto Suture Endoscopic Fascia Stapler

by United States Surgical, A Division of Tyco Healthc

510(k) K912097

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

Recall on shared 510(k) K912097; other models may be affected

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 NumberK912097 Date19 Sep 1991ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2252-2020 FDA Class II initiated 12 May 2020 on shared 510(k) K912097
    • Ongoing Z-2253-2020 FDA Class II initiated 12 May 2020 on shared 510(k) K912097
    • Ongoing Z-2254-2020 FDA Class II initiated 12 May 2020 on shared 510(k) K912097
    • Ongoing Z-2255-2020 FDA Class II initiated 12 May 2020 on shared 510(k) K912097

    The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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