BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Acclarent ENT Navigation System

    Reg #: 3005172759 · FEI: 3005172759 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ACCLARENT, INC.
    Registration Number
    3005172759
    FEI Number
    3005172759
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    31 Technology Dr Suite 200
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173628

    Owner / Operator

    Firm Name
    ACCLARENT, INC.
    Operator Number
    9068915
    Address
    31 TECHNOLOGY DRIVE, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Ear, Nose, And Throat Stereotaxic Instrument PGW

    Proprietary Names

    Acclarent ENT Navigation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility