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FDA 510(k)

Flexible Video Cysto-Urethroscope (C-view)

K-Number: K202957 · 2020-10-29

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2020-10-29
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Video Cysto-Urethroscope (C-view) is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2020-10-29 under approval number K202957. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Video Cysto-Urethroscope (C-view)?

Flexible Video Cysto-Urethroscope (C-view) is a medical device that received FDA 510(k) clearance on 2020-10-29. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K202957.

When was Flexible Video Cysto-Urethroscope (C-view) approved by the FDA?

Flexible Video Cysto-Urethroscope (C-view) received FDA 510(k) clearance on 2020-10-29, under approval number K202957.

What company makes Flexible Video Cysto-Urethroscope (C-view)?

Flexible Video Cysto-Urethroscope (C-view) is manufactured by KARL STORZ Endoscopy-America, Inc..

What is the FDA product code for Flexible Video Cysto-Urethroscope (C-view)?

The FDA product code for Flexible Video Cysto-Urethroscope (C-view) is FAJ.

Other Devices by KARL STORZ Endoscopy-America, Inc.

K161112KARL STORZ Flexible Video-Neuro-Endoscope System K152583KARL STORZ Endoscopic ICG Imaging System K171717AUTOCON III 400 K171238KARL STORZ ICG Imaging System K170462KARL STORZ ShuntScope K161554ENDOFLATOR 40, ENDOFLATOR 50

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Related Devices (Code: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, 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.

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