FDA 510(k)

Single-Use Video Flexible Ureterorenoscope System

Número K: K221158 · 2023-03-06

RequerenteGuangzhou Red Pine Medical Instrument Co., Ltd.

Data da decisão2023-03-06

Código do produtoFGB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single-Use Video Flexible Ureterorenoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K221158. 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 Single-Use Video Flexible Ureterorenoscope System?

Single-Use Video Flexible Ureterorenoscope System is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K221158.

When did Single-Use Video Flexible Ureterorenoscope System receive FDA 510(k) clearance?

Single-Use Video Flexible Ureterorenoscope System received FDA 510(k) clearance on 2023-03-06, under 510(k) number K221158.

Who is the listed applicant for Single-Use Video Flexible Ureterorenoscope System?

The FDA 510(k) record lists Guangzhou Red Pine Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Video Flexible Ureterorenoscope System?

The FDA product code for Single-Use Video Flexible Ureterorenoscope System is FGB.

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Outros registros que listam Guangzhou Red Pine Medical Instrument Co., Ltd. como candidato(a)

K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)K243321Endoscopic Video Image Processor (RP-IPD-V1000F)K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

Ver todos os 10 dispositivos →

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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