BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FLEX SFM System

    Reg #: 3021969326 · FEI: 3021969326 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GI WINDOWS
    Registration Number
    3021969326
    FEI Number
    3021969326
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    381 University Ave.
    City
    Westwood
    State
    MA
    ZIP
    02090
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243213

    Owner / Operator

    Firm Name
    GI Windows
    Operator Number
    10090756
    Address
    381 University Ave.
    City
    Westwood
    State
    MA
    Postal Code
    02090
    Country
    US
    Correspondent
    Yverre Bobay

    Products

    Device Name Product Code
    Magnetic Compression Anastomosis System SAH

    Proprietary Names

    FLEX SFM System

    Establishment Types

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