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FDA 510(k)

Pure Vu System

K-Number: K181437 · 2018-06-21

Decision Date2018-06-21
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 2018-06-21 under approval number K181437. 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 2018-06-21. It is manufactured by Motus GI Medical Technologies , Ltd.. The 510(k) number is K181437.

When was Pure Vu System approved by the FDA?

Pure Vu System received FDA 510(k) clearance on 2018-06-21, under approval number K181437.

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.

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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.