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PMS 750 Fingerswitch

by Wallach Surgical Devices, Inc.

510(k) K991669

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK991669 Date12 Aug 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 27 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 PMS 750 Fingerswitch is a device used in general and plastic surgery procedures. It is a finger-operated switch designed for use with surgical equipment.

The device is supplied as a reusable component and is intended for use in clinical settings. It has received FDA 510(k) clearance under product code GEI and is classified as a Class II medical device. No information regarding sterility, MRI safety, sizes, or storage conditions is provided in the data.

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Questions

AI-generated answers, 27 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 PMS 750 Fingerswitch used for?

    The PMS 750 Fingerswitch is a finger-operated switch designed for use with surgical equipment in general and plastic surgery procedures, allowing clinicians to control devices without breaking sterility or adjusting hand position.

  • Is the PMS 750 Fingerswitch reusable or single-use?

    The PMS 750 Fingerswitch is supplied as a reusable component, meaning it can be cleaned and reused multiple times in clinical settings according to the manufacturer's instructions for cleaning and maintenance.

  • What regulatory pathway was used for the PMS 750 Fingerswitch?

    The PMS 750 Fingerswitch received FDA 510(k) clearance under product code GEI, demonstrating it is substantially equivalent to a legally marketed predicate device, and is classified as a Class II medical device.