Pure Vu System

Colonoscope And Accessories, Flexible/rigid

Motus GI Medical Technologies Ltd.

The following data is part of a premarket notification filed by Motus Gi Medical Technologies Ltd. with the FDA for Pure Vu System.

Pre-market Notification Details

Device IDK191220
510k NumberK191220
Device Name:Pure Vu System
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant Motus GI Medical Technologies Ltd. 22 Keren Ha'yesod St. Tirat Carmel,  IL 3902638
ContactRavit Peled
CorrespondentRandy Prebula
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-07
Decision Date2019-06-06

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