Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pure Vu System

K-Number: K191220 · 2019-06-06

Decision Date2019-06-06
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 2019-06-06 under approval number K191220. 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 2019-06-06. It is manufactured by Motus GI Medical Technologies , Ltd.. The 510(k) number is K191220.

When was Pure Vu System approved by the FDA?

Pure Vu System received FDA 510(k) clearance on 2019-06-06, under approval number K191220.

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

View on FDA Database →

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