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Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode

by Unimed Surgical Products, Inc.

510(k) K962935

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

13 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 NumberK962935 Date3 Sep 1996ClearedStatusActive

Recalls

13 recalls · FDA

    • Terminated Z-1347-2013 FDA Class II initiated 15 Feb 2013

    Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.

  • 11 recalls, same reason

    • 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
    • Terminated Z-2286-2012 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.

    • Terminated Z-0069-2010 FDA Unclassified (pre-2012) initiated 28 Aug 2009

    Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03.

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  • Withdrawn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

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Unimed Coated Needle Electrode Coated Blade Electrode Coated Ball Electrode is an electrosurgical electrode used for the cutting and coagulation of soft tissue. It is designed for use in various surgical procedures. The device is available in different types, including needle, blade, and ball electrodes. It is used to facilitate surgical procedures by providing a means of cutting and coagulating tissue. The device is intended for use in a surgical setting.

The Unimed Coated Needle Electrode Coated Blade Electrode Coated Ball Electrode is supplied by Unimed Surgical Products, Inc. and has been authorized by the FDA under the 510K clearance process, with the reference number K962935. The device is classified under the product code GEI. It is substantially equivalent to other Unimed coated electrosurgical electrodes. The device is used in general and plastic surgery applications.

Other devices from Unimed Surgical Products, Inc.

See all devices from Unimed Surgical Products, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Unimed Coated Electrode used for?

    The Unimed Coated Electrode is used for the cutting and coagulation of soft tissue in various surgical procedures, including general and plastic surgery applications.

  • What types of electrodes are available?

    The Unimed Coated Electrode is available in different types, including needle, blade, and ball electrodes, to facilitate various surgical procedures.

  • Is the Unimed Coated Electrode supplied sterile?

    The description does not specify if the Unimed Coated Electrode is supplied sterile, but it is intended for use in a surgical setting where sterility is typically required.

  • What is the regulatory status of the Unimed Coated Electrode?

    The Unimed Coated Electrode has been authorized by the FDA under the 510K clearance process, with the reference number K962935, and is classified under the product code GEI.