Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

Laparoscope, Gynecologic (and Accessories)

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endoeye Flex Deflectable Videoscope Olympus Ltf-s190-5.

Pre-market Notification Details

Device IDK201832
510k NumberK201832
Device Name:Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentJon Gilbert
Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-02
Decision Date2021-09-17

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