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FDA 510(k)

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

N.º K: K252176 · 2025-08-08

SolicitanteGuangzhou Red Pine Medical Instrument Co., Ltd.
Fecha de decisión2025-08-08
Código de productoFAJ
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

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 2025-08-08 under 510(k) number K252176. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)?

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K252176.

When did Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) receive FDA 510(k) clearance?

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) received FDA 510(k) clearance on 2025-08-08, under 510(k) number K252176.

Who is the listed applicant for 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 Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)?

The FDA product code for Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) is FAJ.

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

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Dispositivos relacionados (Código: FAJ)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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