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

    Single-use Ureteral Access Sheath

    K Number: K240167 · Decision Oct 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    17
    Review Days
    260

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    Basic Information

    Device Name
    Single-use Ureteral Access Sheath
    K Number
    K240167
    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
    January 22, 2024
    Decision Date
    October 8, 2024
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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    Other Clearances by Hunan Vathin Medical Instrument Co., Ltd.

    K Number Device Name
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    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
    K242535 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)
    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)
    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. →