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FDA 510(k)

Third Eye Panoramic Auxiliary Endoscopy System - Resposable

K-Number: K160356 · 2016-05-17

ApplicantAvantis Medical Systems, Inc.
Decision Date2016-05-17
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Third Eye Panoramic Auxiliary Endoscopy System - Resposable is the device name listed in this FDA 510(k) record. The listed applicant is Avantis Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K160356. 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 Third Eye Panoramic Auxiliary Endoscopy System - Resposable?

Third Eye Panoramic Auxiliary Endoscopy System - Resposable is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Avantis Medical Systems, Inc.. The 510(k) number is K160356.

When did Third Eye Panoramic Auxiliary Endoscopy System - Resposable receive FDA 510(k) clearance?

Third Eye Panoramic Auxiliary Endoscopy System - Resposable received FDA 510(k) clearance on 2016-05-17, under 510(k) number K160356.

Who is the listed applicant for Third Eye Panoramic Auxiliary Endoscopy System - Resposable?

The FDA 510(k) record lists Avantis Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Third Eye Panoramic Auxiliary Endoscopy System - Resposable?

The FDA product code for Third Eye Panoramic Auxiliary Endoscopy System - Resposable is FDF.

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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