BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sidecar External Working Channel (FG-1011)

    Reg #: 3008780134 · FEI: 3008780134 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Pentax of America, Inc.
    Registration Number
    3008780134
    FEI Number
    3008780134
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    303 Convention Way Ste 1 Ste 3
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150083

    Owner / Operator

    Firm Name
    HOYA Corporation PENTAX Division
    Operator Number
    8030235
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    Postal Code
    07645
    Country
    US
    Correspondent
    Gurvinder Nanda

    Products

    Device Name Product Code
    Endoscopic Access Overtube, Gastroenterology-Urology FED

    Proprietary Names

    Sidecar External Working Channel (FG-1011)

    Establishment Types

    Manufacture Medical Device