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

    Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

    K Number: K233778 · Decision Jul 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    7
    Review Days
    232

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    Basic Information

    Device Name
    Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
    K Number
    K233778
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhuhai Pusen Medical Technology Co., Ltd.
    Date Received
    November 27, 2023
    Decision Date
    July 16, 2024
    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 Clearances by Zhuhai Pusen Medical Technology Co., Ltd.

    K Number Device Name
    K260521 ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
    K223741 Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)
    K222602 Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)
    K190648 Pusen Eview Medical Video Endoscope Image Processor
    K172098 Medical Video Endoscope System
    K171076 Medical Video Endoscope System