BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

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

    K Number: K252176 · Decision Aug 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    9
    Review Days
    28

    Basic Information

    Device Name
    Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
    K Number
    K252176
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Red Pine Medical Instrument Co., Ltd.
    Date Received
    July 11, 2025
    Decision Date
    August 8, 2025
    Product Code
    FAJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FAJ Cystoscope And Accessories, Flexible/Rigid

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    Other Clearances by Guangzhou Red Pine Medical Instrument Co., Ltd.

    K Number Device Name
    K251951 Single-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)
    K243321 Endoscopic Video Image Processor (RP-IPD-V1000F)
    K241987 Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
    K241500 Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
    K240663 Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
    K232043 Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
    K232003 Endoscopic Video Image Processor, Single-Use Video Hysteroscope
    K221158 Single-Use Video Flexible Ureterorenoscope System