FDA 510(k)

Aer-O-Scope Colonoscope System

K-Number: K230588 · 2023-08-17

Decision Date2023-08-17

Product CodeFDF

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Aer-O-Scope Colonoscope System is a medical device manufactured by Gi View , Ltd.. It received FDA 510(k) clearance on 2023-08-17 under approval number K230588. 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 Aer-O-Scope Colonoscope System?

Aer-O-Scope Colonoscope System is a medical device that received FDA 510(k) clearance on 2023-08-17. It is manufactured by Gi View , Ltd.. The 510(k) number is K230588.

When was Aer-O-Scope Colonoscope System approved by the FDA?

Aer-O-Scope Colonoscope System received FDA 510(k) clearance on 2023-08-17, under approval number K230588.

What company makes Aer-O-Scope Colonoscope System?

Aer-O-Scope Colonoscope System is manufactured by Gi View , Ltd..

What is the FDA product code for Aer-O-Scope Colonoscope System?

The FDA product code for Aer-O-Scope Colonoscope System is FDF.

Other Devices by Gi View , Ltd.

K161791Aer-O-Scope Colonoscope 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

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