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Auto Suture* Modified Endoscopic Fascia Stapler** Device

by United States Surgical, A Division of Tyco Healthc

510(k) K963999

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 NumberK963999 Date27 Nov 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1157-2010 FDA Unclassified (pre-2012) initiated 8 Feb 2010 on shared 510(k) K963999

    Fixation device may fail to fire and staple.

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  • Withdrawn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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