Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch

Electrosurgical, Cutting & Coagulation & Accessories

Megadyne Medical Products, Inc.

The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch.

Pre-market Notification Details

Device IDK193145
510k NumberK193145
Device Name:Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Megadyne Medical Products, Inc. 11506 South State Street Draper,  UT  84020
ContactSharon Sussex
CorrespondentKweku Biney
Ethicon Endo-Surgery LLC 4545 Creek Road Cincinnati,  OH  45242
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-13
Decision Date2020-03-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10614559105597 K193145 000
10614559105634 K193145 000

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