Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps

Electrosurgical, Cutting & Coagulation & Accessories

Olympus Winter & Ibe GmbH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Electrosurgical Generator Esg-410, Foot Switches, Pk Cutting Forceps.

Pre-market Notification Details

Device IDK203277
510k NumberK203277
Device Name:Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg,  DE 22045
ContactJan-oliver Upmeier
CorrespondentChristina Flores
Olympus Surgical Technologies America 118 Turnpike Road Southborough,  MA  01772
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-06
Decision Date2021-04-28

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