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Reprocessed Electrosurgical Electrodes

by Surgical Instruments Service and Savings, Inc.

510(k) K012669

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 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 NumberK012669 Date27 Jun 2002ClearedStatusActive

Recalls

5 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1547-2025 FDA Class II initiated 5 Mar 2025
    • Ongoing Z-1546-2025 FDA Class II initiated 5 Mar 2025
    • Ongoing Z-1549-2025 FDA Class II initiated 5 Mar 2025

    Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

  • 2 recalls, same reason

    • Terminated Z-1628-2013 FDA Class II initiated 3 May 2013
    • Terminated Z-1644-2013 FDA Class II initiated 3 May 2013 on shared 510(k) K012669

    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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