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FDA 510(k)

Pure-Vu System

K-Number: K173392 · 2017-12-12

Decision Date2017-12-12
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pure-Vu System is a medical device manufactured by Motus GI Medical Technologies , Ltd.. It received FDA 510(k) clearance on 2017-12-12 under approval number K173392. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pure-Vu System?

Pure-Vu System is a medical device that received FDA 510(k) clearance on 2017-12-12. It is manufactured by Motus GI Medical Technologies , Ltd.. The 510(k) number is K173392.

When was Pure-Vu System approved by the FDA?

Pure-Vu System received FDA 510(k) clearance on 2017-12-12, under approval number K173392.

What company makes Pure-Vu System?

Pure-Vu System is manufactured by Motus GI Medical Technologies , Ltd..

What is the FDA product code for Pure-Vu System?

The FDA product code for Pure-Vu System is FDF.

Other Devices by Motus GI Medical Technologies , Ltd.

View all 7 devices →

Related Devices (Code: FDF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.