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Acufex Mosaicplasty Comprehensive System

by Smith & Nephew Endoscopy, Inc.

510(k) K964215

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK964215 Date20 Dec 1996ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0156-2016 FDA Class II initiated 10 Sep 2015 on shared 510(k) K964215
    • Terminated Z-0158-2016 FDA Class II initiated 10 Sep 2015 on shared 510(k) K964215
    • Terminated Z-0155-2016 FDA Class II initiated 10 Sep 2015 on shared 510(k) K964215
    • Terminated Z-0157-2016 FDA Class II initiated 10 Sep 2015 on shared 510(k) K964215

    Sterility of device is compromised due to breach in the packaging

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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