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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 a medical device manufactured by Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 2022-01-21 under approval 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. It is manufactured by Megadyne Medical Products, Inc.. The 510(k) number is K213696.

When was ETHICON Megadyne Electrosurgical Generator approved by the FDA?

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

What company makes ETHICON Megadyne Electrosurgical Generator?

ETHICON Megadyne Electrosurgical Generator is manufactured by Megadyne Medical Products, Inc..

What is the FDA product code for ETHICON Megadyne Electrosurgical Generator?

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

Related Clinical Trials

NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING

Other Devices by Megadyne Medical Products, Inc.

K191328Megadyne Foot Switch 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 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)

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Official Source

View on FDA Database →

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

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