BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SINUSCOPE 4MM 45 DEGREE (8855-WA)

    Reg #: 2518897 · FEI: 1000080301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    1

    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
    K944656

    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
    Nasopharyngoscope (Flexible Or Rigid) EOB

    Proprietary Names

    SINUSCOPE 4MM 45 DEGREE (8855-WA) CONNECTOR TO LIGHT SOURCE (8876) SINUSCOPE 2.7MM, 0 WIDE ANGLE (8850-WA) SUCTION/IRRIGATION HANDLE (8857) LIGHT CABLE3.5 X 2300 (8870) SINUSCOPE, 2.7MM 0 DEG, 175MM (8850) SINUSCOPE 2.7MM, 30 WIDE ANGLE (8851-WA) SINUSCOPE 4MM, 70 WIDE ANGLE (8856-WA) SINUSCOPE 4MM, 0 WIDE ANGLE (8853-WA) OTOSCOPE SHEATH (8869) HANDLE FOR INSERT (8862) SINUSCOPE 2.7MM, 70 WIDE ANGLE (8852-WA) CONNECTOR TO LIGHT SOURCE (8874) CONNECTOR/LIGHT SOURCE OLYMPUS (8875) SINUSCOPE 4MM, 0 DEG 175MM (8853) OTOSCOPE 3MM, 69MM LONG (8868) SINUSCOPE 4MM, 30 WIDE ANGLE (8854-WA) ADAPTABLE TUBE (8860) CONNECTOR TO SCOPE (8872) CONNECTOR TO LIGHT SOURCE (8877) SINUSCOPE 2.7MM, 30 (8851) SINUSCOPE 2.7MM, 70 (8852) SINUSCOPE, 4MM 30 DEG 175MM (8854) CONNECTOR TO SCOPE (8871) SINUSCOPE, 4MM, 45 DEG, 175MM (8855) ADAPTABLE TUBE (8861) STERILIZATION BASKET (8845) CONNECTOR/LIGHT SOURCE PENTAX (8879) SINUSCOPE, 4MM, 70 DEG, 175MM (8856)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198