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 IDK210981
510k NumberK210981
Device Name:Pure Vu System
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant Motus GI Medical Technologies Ltd. 22 Keren Ha'yesod Str. Tirat Carmel,  IL 3902638
ContactMark Pomeranz
CorrespondentMark Pomeranz
Motus GI Medical Technologies Ltd. 22 Keren Ha'yesod Str. Tirat Carmel,  IL 3902638
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-01
Decision Date2021-04-29

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