Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch

K-Number: K193145 · 2020-03-24

ApplicantMegadyne Medical Products, Inc.
Decision Date2020-03-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is a medical device manufactured by Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 2020-03-24 under approval number K193145. 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, Bipolar Footswitch?

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

When was Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch approved by the FDA?

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

What company makes Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is manufactured by Megadyne Medical Products, Inc..

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.

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 K213696ETHICON Megadyne Electrosurgical Generator 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)

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑