BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GERDX-System

    Reg #: 3032855354 · FEI: 3032855354 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    G-SURG USA, INC.
    Registration Number
    3032855354
    FEI Number
    3032855354
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    80 Pine St Fl 24
    City
    New York
    State
    NY
    ZIP
    10005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233240

    Owner / Operator

    Firm Name
    G-SURG USA, Inc.
    Operator Number
    10091642
    Address
    80 Pine Street, Floor 24
    City
    New York
    State
    NY
    Postal Code
    10005
    Country
    US
    Correspondent
    Julian Mair

    Products

    Device Name Product Code
    Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) ODE

    Proprietary Names

    GERDX-System GERDX-Suture System GERDX-Tissue Retractor GERDX-Applicator GERDX-Guide Wire

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198