ViziShot 2 FLEX

Bronchoscope Accessory

Olympus Surgical Technologies America

The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Vizishot 2 Flex.

Pre-market Notification Details

Device IDK193517
510k NumberK193517
Device Name:ViziShot 2 FLEX
ClassificationBronchoscope Accessory
Applicant Olympus Surgical Technologies America 136 Turnpike Road Southborough,  MA  01772 -2104
ContactMary Anne Patella
CorrespondentMary Anne Patella
Olympus Surgical Technologies America 136 Turnpike Road Southborough,  MA  01772 -2104
Product CodeKTI  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyEar Nose & Throat
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-03-18

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