BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WiScope® Single-Use Digital Flexible Ureteroscope

    Reg #: 3013992977 · FEI: 3013992977 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OTU Medical Inc
    Registration Number
    3013992977
    FEI Number
    3013992977
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2847A Whipple Rd.
    City
    Union City
    State
    CA
    ZIP
    94587
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181977

    Owner / Operator

    Firm Name
    OTU MEDICAL INC.
    Operator Number
    10058788
    Address
    2847 Whipple Rd., Ste. A, Union City, CA 94587
    City
    Union City
    State
    CA
    Postal Code
    94587
    Country
    US
    Correspondent
    GEPING LIU

    Products

    Device Name Product Code
    Ureteroscope And Accessories, Flexible/Rigid FGB

    Proprietary Names

    WiScope® Single-Use Digital Flexible Ureteroscope WiScope® Single-Use Digital Flexible UroScope WiScope® Digital Endoscope System Aptra™ Image System WiScope® Image System Aptra™ Digital Endoscope System Aptra™ Single-Use Digital Flexible Ureteroscope

    Establishment Types

    Manufacture Medical Device