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Wallach Integration Unit

by Wallach Surgical Devices, Inc.

510(k) K963348

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963348 Date19 Mar 1997ClearedStatusActive

Recalls

4 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0258-2022 FDA Class II initiated 29 Sep 2021
    • Ongoing Z-0257-2022 FDA Class II initiated 29 Sep 2021

    Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

    • Terminated Z-2057-2019 FDA Class II initiated 18 Jun 2019

    The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.

    • Terminated Z-1840-2019 FDA Class II initiated 23 Apr 2019

    2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.

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  • Withdrawn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
HGI
Device Class
Class II
Regulation
21 CFR Part 884.4120
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Wallach Integration Unit is an electrocautery device used in obstetrics and gynecology. It is designed to interface with electrosurgical generators to enable automatic activation of a smoke evacuator when the device is in cut or coag mode.

The device is supplied as a reusable unit for use in clinical settings. It received FDA 510(k) clearance under K963348 and is classified as a Class II medical device. No information on sterility, MRI safety, sizes, or storage is provided in the data.

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Questions

AI-generated answers, 6 Oct 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 Wallach Integration Unit used for?

    The Wallach Integration Unit is an electrocautery device used in obstetrics and gynecology to interface with electrosurgical generators, enabling automatic activation of a smoke evacuator when the device is in cut or coag mode, improving surgical smoke management during procedures.

  • Is the Wallach Integration Unit reusable or single-use?

    The Wallach Integration Unit is supplied as a reusable unit for use in clinical settings, meaning it is designed for multiple uses after appropriate cleaning and reprocessing between patients, as indicated in the device description.

  • What regulatory clearance does the Wallach Integration Unit have?

    The Wallach Integration Unit received FDA 510(k) clearance under K963348 and is classified as a Class II medical device, confirming its substantial equivalence to a legally marketed predicate device for its intended use.