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Megadyne Foot Switch

by Megadyne Medical Products, Inc.

510(k) K191328

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 NumberK191328 Date26 Jul 2019ClearedStatusActive

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  • Withdrawn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
FYD
Device class
Class II
Regulation
21 CFR Part 878.5070
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Megadyne Foot Switch is an accessory intended to interface with compatible smoke evacuation systems to control on/off inputs for manual operation. It is a device used in general and plastic surgery settings as part of surgical smoke management systems.

The device is supplied as a reusable accessory and is regulated under FDA 510(k) clearance (K191328) as a Class II device. It complies with IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility. No information is provided regarding sterility, MRI safety, sizes, or storage conditions.

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Questions

AI-generated answers, 1 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 Megadyne Foot Switch used for?

    The Megadyne Foot Switch is an accessory intended to interface with compatible smoke evacuation systems to control on/off inputs for manual operation. It is used in general and plastic surgery settings as part of surgical smoke management systems, allowing clinicians to activate or deactivate the smoke evacuator hands-free during procedures.

  • Is the Megadyne Foot Switch reusable or single-use?

    The Megadyne Foot Switch is supplied as a reusable accessory, meaning it is designed for multiple uses after appropriate cleaning and disinfection between procedures, as it is not provided sterile and is not intended for single-use disposal.

  • What regulatory pathway was used for the Megadyne Foot Switch?

    The Megadyne Foot Switch received FDA 510(k) clearance under submission K191328, indicating it was found substantially equivalent to a legally marketed predicate device. It is regulated as a Class II medical device and complies with IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.