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FDA 510(k)

Pure Vu System

K-Number: K181437 · 2018-06-21

ApplicantMotus GI Medical Technologies , Ltd.
Decision Date2018-06-21
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pure Vu System 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 2018-06-21 under 510(k) 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. The listed applicant is Motus GI Medical Technologies , Ltd.. The 510(k) number is K181437.

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

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

Who is the listed applicant for Pure Vu System?

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 System?

The FDA product code for Pure Vu System 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 SystemK173392Pure-Vu SystemK160015Pure Vu

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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.

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