FDA 510(k)

Flexible Video Cysto-Urethroscope (C-view)

Número K: K202957 · 2020-10-29

RequerenteKARL STORZ Endoscopy-America, Inc.

Data da decisão2020-10-29

Código do produtoFAJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K202957.

When did Flexible Video Cysto-Urethroscope (C-view) receive FDA 510(k) clearance?

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

Who is the listed applicant for Flexible Video Cysto-Urethroscope (C-view)?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Fonte oficial

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