Ultrasonic Bipolar Generator USG-410 With Accessories

Instrument, Ultrasonic Surgical

Olympus Medical Systems Corporation

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Ultrasonic Bipolar Generator Usg-410 With Accessories.

Pre-market Notification Details

Device IDK211838
510k NumberK211838
Device Name:Ultrasonic Bipolar Generator USG-410 With Accessories
ClassificationInstrument, Ultrasonic Surgical
Applicant Olympus Medical Systems Corporation 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentAnne-marie Keefe
Olympus Surgical Technologies Of America 800 West Park Drive Westborough,  MA  01581
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-14
Decision Date2021-08-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170410758 K211838 000
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14953170465045 K211838 000
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14953170343343 K211838 000
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14953170383578 K211838 000
14953170383547 K211838 000
14953170383516 K211838 000
14953170370608 K211838 000
14953170464994 K211838 000

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