FDA 510(k)

Megadyne Foot Switch

K-Number: K191328 · 2019-07-26

ApplicantMegadyne Medical Products, Inc.

Decision Date2019-07-26

Product CodeFYD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Megadyne Foot Switch is the device name listed in this FDA 510(k) record. The listed applicant is Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191328. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Megadyne Foot Switch?

Megadyne Foot Switch is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K191328.

When did Megadyne Foot Switch receive FDA 510(k) clearance?

Megadyne Foot Switch received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191328.

Who is the listed applicant for Megadyne Foot Switch?

The FDA 510(k) record lists Megadyne Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Megadyne Foot Switch?

The FDA product code for Megadyne Foot Switch is FYD.

Other records listing Megadyne Medical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)K213696ETHICON Megadyne Electrosurgical Generator K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor K193145Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch

Related Devices (Code: FYD)

K240127PlumeSafe X5 Smoke Management SystemConmed Corporation K2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation K213068Medline Smoke Evacuation ShroudMedline Industries, Inc.K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.