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FDA 510(k)

ETHICON Megadyne Electrosurgical Generator

K-Number: K213696 · 2022-01-21

ApplicantMegadyne Medical Products, Inc.
Decision Date2022-01-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ETHICON Megadyne Electrosurgical Generator 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 2022-01-21 under 510(k) number K213696. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHICON Megadyne Electrosurgical Generator?

ETHICON Megadyne Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K213696.

When did ETHICON Megadyne Electrosurgical Generator receive FDA 510(k) clearance?

ETHICON Megadyne Electrosurgical Generator received FDA 510(k) clearance on 2022-01-21, under 510(k) number K213696.

Who is the listed applicant for ETHICON Megadyne Electrosurgical Generator?

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?

The FDA product code for ETHICON Megadyne Electrosurgical Generator is GEI.

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)K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorK193145Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchK191328Megadyne Foot Switch

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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.

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