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Needle Elctrode

by Unimed Surgical Products, Inc.

510(k) K944265

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

11 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 NumberK944265 Date5 May 1995ClearedStatusActive

Recalls

11 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-2286-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2287-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2293-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2292-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2288-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2295-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2291-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2296-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2289-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2290-2012 FDA Class II initiated 16 Jun 2010
    • Terminated Z-2294-2012 FDA Class II initiated 16 Jun 2010

    On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.

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  • Withdrawn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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