FDA 510(k)

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System

Número K: K212202 · 2022-04-13

Data da decisão2022-04-13

Código do produtoFAJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System is the device name listed in this FDA 510(k) record. The listed applicant is OTU Medical, Inc.. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K212202. 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 WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System?

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is OTU Medical, Inc.. The 510(k) number is K212202.

When did WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System receive FDA 510(k) clearance?

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System received FDA 510(k) clearance on 2022-04-13, under 510(k) number K212202.

Who is the listed applicant for WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System?

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

What is the FDA product code for WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System?

The FDA product code for WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System is FAJ.

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Outros registros que listam OTU Medical, Inc. como candidato(a)

K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System K210579Sistema de Endoscopia OM WiScope, Ureteroscópio Flexível Digital de Uso Único WiScope. Choledocóscopio, Sistema de Imagem WiScope K181977WiScope Digital Endoscope System

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