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

    Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

    K Number: K242535 · Decision Dec 18, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    17
    Review Days
    114

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    Basic Information

    Device Name
    Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)
    K Number
    K242535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hunan Vathin Medical Instrument Co., Ltd.
    Date Received
    August 26, 2024
    Decision Date
    December 18, 2024
    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 Hunan Vathin Medical Instrument Co., Ltd.

    K Number Device Name
    K250232 Vathin® Video Bronchoscope System
    K251599 Single-use Ureteral Access Sheath
    K250785 Single-use Flexible Ureteroscope
    K243117 Digital Video Processor
    K242416 Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL
    K241612 Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
    K240167 Single-use Ureteral Access Sheath
    K241434 Video Ureteroscope System
    K231135 Video Ureteroscope System
    K230536 Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
    Search all 17 clearances from Hunan Vathin Medical Instrument Co., Ltd. →