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Electrosurgical Cutting and Coagulation Accessories, Electrosurgical Wands

by Medical Instruments Technology, Inc.

510(k) K012640

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK012640 Date28 Feb 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1680-2008 FDA Unclassified (pre-2012) initiated 11 Mar 2008

    Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 electrosurgical wand is an accessory designed for cutting and coagulation of tissue during orthopedic joint surgery. It connects to a system controller and power source, and the operator selects cutting or coagulation functions with a foot‑pedal.

The wand is supplied as a reprocessed device intended for reuse after appropriate reprocessing. It was cleared through the FDA 510(k) pathway (K012640) with a traditional clearance type and product code HRX. The submission was reviewed by the Orthopedic advisory committee and is classified for use in the United States.

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