BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GI WINDOWS

    Reg #: 3021969326 · FEI: 3021969326 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    GI WINDOWS
    Registration Number
    3021969326
    FEI Number
    3021969326
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    480 Neponset St Ste 11b1
    City
    Canton
    State
    MA
    ZIP
    02021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243482

    Owner / Operator

    Firm Name
    GI Windows
    Operator Number
    10090756
    Address
    480 Neponset St., Ste. 11B1
    City
    Canton
    State
    MA
    Postal Code
    02021
    Country
    US
    Correspondent
    Yverre Bobay

    Products

    Device Name Product Code
    Magnetic Compression Anastomosis System SAH
    Forceps, General & Plastic Surgery GEN

    Proprietary Names

    Flexagon SFM System Titanium Grasper Flexagon SFM Plus OTOLoc System (FlexFie Universal Laparoscopic Delivery)

    Establishment Types

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