Thunderbeat Open Fine Jaw Type X Hand Instrument

Electrosurgical, Cutting & Coagulation & Accessories

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Thunderbeat Open Fine Jaw Type X Hand Instrument.

Pre-market Notification Details

Device IDK192103
510k NumberK192103
Device Name:Thunderbeat Open Fine Jaw Type X Hand Instrument
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentChristina Flores
Gyrus ACMI Inc. 136 Turnpike Road Southborough,  MA  01772
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-05
Decision Date2020-05-11

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.