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Medline ReNewal Reprocessed Harmonic ACE+7 Shears

by Surgical Instrument Service and Savings Inc.(Dba Medline Ren

510(k) K193563

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 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 NumberK193563 Date19 Aug 2020ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-3095-2024 FDA Class II initiated 7 May 2024

    Potential for an incomplete seal on the packaging tray.

    • Ongoing Z-0120-2024 FDA Class II initiated 3 Aug 2023

    Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

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  • Withdrawn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
NLQ
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Other devices from Surgical Instrument Services and Savings(Dba Medline Renewal