BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Single Use Biopsy Valve,90,i10,i10c (GAR018P)

    Reg #: 2518897 · FEI: 1000080301 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PENTAX of America, Inc.
    Registration Number
    2518897
    FEI Number
    1000080301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3 Paragon Drive
    City
    MONTVALE
    State
    NJ
    ZIP
    07645
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181509

    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
    Endoscope Channel Accessory ODC
    Endoscopic Irrigation/Suction System OCX

    Proprietary Names

    Single Use Biopsy Valve,90,i10,i10c (GAR018P) Single Use 2 Piece Valve Set,90,i10,i10c (GAR037C) Single Use Aux Water Conn,90,i10,i10c (GAR048) Single Use 4 Piece Valve Set,90,i10,i10c (GAR081P) Single Use 3 Piece Valve Set,90,i10,i10c (GAR037P)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198