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Autosuture Endoscopic Suturing Device

by United States Surgical, A Division of Tyco Healthc

510(k) K934738

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK934738 Date16 Mar 1994ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2281-2026 FDA Class II initiated 15 Apr 2026

    The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

    • Terminated Z-2543-2017 FDA Class II initiated 3 May 2017 on shared 510(k) K934738

    Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

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  • Withdrawn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

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