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

FDA 510(k)

Pure Vu

K-Number: K160015 · 2016-09-22

ApplicantMotus GI Medical Technologies , Ltd.
Decision Date2016-09-22
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pure Vu is the device name listed in this FDA 510(k) record. The listed applicant is Motus GI Medical Technologies , Ltd.. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K160015. 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?

Pure Vu is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Motus GI Medical Technologies , Ltd.. The 510(k) number is K160015.

When did Pure Vu receive FDA 510(k) clearance?

Pure Vu received FDA 510(k) clearance on 2016-09-22, under 510(k) number K160015.

Who is the listed applicant for Pure Vu?

The FDA 510(k) record lists Motus GI Medical Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pure Vu?

The FDA product code for Pure Vu is FDF.

Other records listing Motus GI Medical Technologies , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232922Pure-Vu EVS SystemK220007Pure-Vu EVS SystemK210981Pure Vu SystemK191220Pure Vu SystemK181437Pure Vu SystemK173392Pure-Vu System

View all 7 devices →

Related Devices (Code: FDF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFujifilm CorporationK250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)Olympus Medical Systems Corporation

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.

↑