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Midas Touch Electrosurgical Electrode

by Iti Medical Technologies, Inc.

510(k) K973234

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK973234 Date27 Oct 1997ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0140-2010 FDA Unclassified (pre-2012) initiated 24 Sep 2009

    THERE WERE INCONSISTENCIES NOTICED ON THE INSULATION OVERLAP. THE ELECTRODE HAS A LARGE DIAMETER SHAFT THAT TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE 1ST LAYER OF INSULATION WHICH COVERS THE SMALL DIAMETER SHAFT OVERLAPS WITH THE 2ND LAYER OF INSULATION THAT COVERS THE LARGER DIAMETER SHAFT. ON SOME ELECTRODES IT APPEARS THAT THE OVERLAP IS TOO SHORT TO COVER THE TRANSITION WHICH MAKES THIS

    • Terminated Z-0182-2007 FDA Unclassified (pre-2012) initiated 29 Aug 2006 on shared 510(k) K973234

    Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.

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  • Withdrawn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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