BEUDAMED
    FDA Registration Active 🇺🇸 United States

    neoClose - NCAAX4-U, (Drivers) NCAGXL-U , NCAAX2-U, NCAGR-U, NCAGRX2-U, NCAG-U (A nchor/Guard)

    Reg #: 3013002341 · FEI: 3013002341 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SHARP FLUIDICS, INC.
    Registration Number
    3013002341
    FEI Number
    3013002341
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25620 Deerfield Dr
    City
    Los Altos Hills
    State
    CA
    ZIP
    94022
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142903

    Owner / Operator

    Firm Name
    Sharp Fluidics, Inc
    Operator Number
    10052447
    Address
    25620 Deerfield Dr
    City
    Los Altos Hills
    State
    CA
    Postal Code
    94022
    Country
    US
    Correspondent
    Douglas G Rimer

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    neoClose - NCAAX4-U, (Drivers) NCAGXL-U , NCAAX2-U, NCAGR-U, NCAGRX2-U, NCAG-U (A nchor/Guard)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198