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

    Single-Use Video Flexible Ureterorenoscope System

    K Number: K221158 · Decision Mar 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    9
    Review Days
    319

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    Basic Information

    Device Name
    Single-Use Video Flexible Ureterorenoscope System
    K Number
    K221158
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    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
    April 21, 2022
    Decision Date
    March 6, 2023
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other 510(k) clearances with the same product code (FGB), ordered by most recent decision date.

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    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)

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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)
    K252176 Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
    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