THUNDERBEAT Open Fine Jaw

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.

Pre-market Notification Details

Device IDK151743
510k NumberK151743
Device Name:THUNDERBEAT Open Fine Jaw
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentGraham A. L. Baillie
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 Received2015-06-29
Decision Date2016-02-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170343343 K151743 000

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