FDA 510(k)

Flexible Video-Choledo-Cysto-Ureteroscope System

Número K: K211686 · 2022-02-22

RequerenteShanghai SeeGen Photoelectric Technology Co., Ltd.

Data da decisão2022-02-22

Código do produtoFGB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flexible Video-Choledo-Cysto-Ureteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K211686. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Flexible Video-Choledo-Cysto-Ureteroscope System?

Flexible Video-Choledo-Cysto-Ureteroscope System is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K211686.

When did Flexible Video-Choledo-Cysto-Ureteroscope System receive FDA 510(k) clearance?

Flexible Video-Choledo-Cysto-Ureteroscope System received FDA 510(k) clearance on 2022-02-22, under 510(k) number K211686.

Who is the listed applicant for Flexible Video-Choledo-Cysto-Ureteroscope System?

The FDA 510(k) record lists Shanghai SeeGen Photoelectric Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System?

The FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System is FGB.

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Outros registros que listam Shanghai SeeGen Photoelectric Technology Co., Ltd. como candidato(a)

K252457Disposable Distal End Tape Hood K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)K222499Disposable Endoscope Valves Kit K222261Flexible Video-Choledochoscope System

Dispositivos Relacionados (Código: FGB)

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

Fonte oficial

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