BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHARP FLUIDICS, INC.

    Reg #: 3013002341 · FEI: 3013002341 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    SHARP FLUIDICS, INC.
    Registration Number
    3013002341
    FEI Number
    3013002341
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    298 CARMEL AVE
    City
    El Granada
    State
    CA
    ZIP
    94018
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173917

    Owner / Operator

    Firm Name
    Sharp Fluidics, Inc
    Operator Number
    10052447
    Address
    298 CARMEL AVE
    City
    El Granada
    State
    CA
    Postal Code
    94018
    Country
    US
    Correspondent
    Douglas G Rimer

    Products

    Device Name Product Code
    Staple, Implantable GDW
    Laparoscope, General & Plastic Surgery GCJ
    Suture, Nonabsorbable, Synthetic, Polyamide GAR

    Proprietary Names

    PDS Anchor 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