BEUDAMED
    FDA Registration Active 🇺🇸 United States

    180 PEAR CATHETER (FG-1027)

    Reg #: 3008780134 · FEI: 3008780134 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    K190194

    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
    Unit, Cryosurgical, Accessories GEH

    Proprietary Names

    180 PEAR CATHETER (FG-1027) FOCAL PEAR CATHETER (FG-1024) CARTRIDGE (FG-1013) FOCAL STANDARD CATHETER (FG-1028) 180 STANDARD CATHETER (FG-1031) CONTROLLER (FG-1017) 360 PEAR CATHETER (FG-1025) 90 PEAR CATHETER (FG-1026) FOOT PEDAL (FG-1018) 90 STANDARD CATHETER (FG-1030) 360 STANDARD CATHETER (FG-1029)

    Establishment Types

    Manufacture Medical Device