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)

G-EYE System

K-Number: K192588 · 2020-04-15

ApplicantSmart Medical Systems , Ltd.
Decision Date2020-04-15
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

G-EYE System is a medical device manufactured by Smart Medical Systems , Ltd.. It received FDA 510(k) clearance on 2020-04-15 under approval number K192588. 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 G-EYE System?

G-EYE System is a medical device that received FDA 510(k) clearance on 2020-04-15. It is manufactured by Smart Medical Systems , Ltd.. The 510(k) number is K192588.

When was G-EYE System approved by the FDA?

G-EYE System received FDA 510(k) clearance on 2020-04-15, under approval number K192588.

What company makes G-EYE System?

G-EYE System is manufactured by Smart Medical Systems , Ltd..

What is the FDA product code for G-EYE System?

The FDA product code for G-EYE System is FDF.

Other Devices by Smart Medical Systems , Ltd.

K202469G-EYE System K220158G-EYE System

Related Devices (Code: FDF)

K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. K160015Pure VuMotus GI Medical Technologies , Ltd. K161355invendoscopy E200 SystemInvendo Medical GmbH K161791Aer-O-Scope Colonoscope SystemGi View , Ltd. K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc.

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.

↑