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Surgical Trocar

by Applied Medical

510(k) K911462

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK911462 Date22 Apr 1991ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1584-2018 FDA Class II initiated 12 Mar 2018

    Products have been packaged with the wrong Trocar length type.

    • Terminated Z-0147-2015 FDA Class II initiated 13 Sep 2013

    CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.

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  • Withdrawn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
DRC
Device Class
Class II
Regulation
21 CFR Part 870.1390
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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