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FDA 510(k)

MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM

K-Number: K093187 · 2009-11-05

ApplicantAvantis Medical Systems, Inc.
Decision Date2009-11-05
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM 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 2009-11-05 under 510(k) number K093187. 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 MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM?

MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-05. The listed applicant is Avantis Medical Systems, Inc.. The 510(k) number is K093187.

When did MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM received FDA 510(k) clearance on 2009-11-05, under 510(k) number K093187.

Who is the listed applicant for MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM?

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 MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM?

The FDA product code for MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM is FDF.

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Other records listing Avantis Medical Systems, Inc. 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.

K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableK091783THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEMK083180THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEMK070330THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY 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.

K260503Triton 1 SystemNeptune Medical, Inc.K261015Solo Scope Colonoscope SystemGi View, Ltd.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.

Official Source

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