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FDA 510(k)

Aer-O-Scope Colonoscope System

K-Number: K161791 · 2016-08-11

ApplicantGi View , Ltd.
Decision Date2016-08-11
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Aer-O-Scope Colonoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Gi View , Ltd.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K161791. 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 2016-08-11. The listed applicant is Gi View , Ltd.. The 510(k) number is K161791.

When did Aer-O-Scope Colonoscope System receive FDA 510(k) clearance?

Aer-O-Scope Colonoscope System received FDA 510(k) clearance on 2016-08-11, under 510(k) number K161791.

Who is the listed applicant for Aer-O-Scope Colonoscope System?

The FDA 510(k) record lists Gi View , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Gi View , 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.

K230588Aer-O-Scope Colonoscope System

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

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

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