FDA 510(k)

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch

Numéro K : K193145 · 2020-03-24

DemandeurMegadyne Medical Products, Inc.

Date de décision2020-03-24

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch 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 2020-03-24 under 510(k) number K193145. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is a medical device that received FDA 510(k) clearance on 2020-03-24. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K193145.

When did Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch receive FDA 510(k) clearance?

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch received FDA 510(k) clearance on 2020-03-24, under 510(k) number K193145.

Who is the listed applicant for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

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 Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

The FDA product code for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is GEI.

Essais cliniques associés

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Autres dossiers indiquant Megadyne Medical Products, Inc. en tant que demandeur

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 K191328Megadyne Foot Switch

Dispositifs connexes (Code : GEI)

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Source officielle

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