FDA 510(k)

Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

Número K: K241500 · 2024-07-12

RequerenteGuangzhou Red Pine Medical Instrument Co., Ltd.

Data da decisão2024-07-12

Código do produtoFAJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) 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 2024-07-12 under 510(k) number K241500. 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 Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)?

Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K241500.

When did Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) receive FDA 510(k) clearance?

Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) received FDA 510(k) clearance on 2024-07-12, under 510(k) number K241500.

Who is the listed applicant for Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)?

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 Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)?

The FDA product code for Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) is FAJ.

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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)K240663Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)

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