BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    stentfix OTSC System Set

    Reg #: 3006696607 · FEI: 3006696607 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    OVESCO ENDOSCOPY AG
    Registration Number
    3006696607
    FEI Number
    3006696607
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Friedrich-Miescher-Strasse 9
    City
    Tuebingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K183309

    Owner / Operator

    Firm Name
    Ovesco Endoscopy
    Operator Number
    10031680
    Address
    15300 Weston Parkway, Suite 101
    City
    Cary
    State
    NC
    Postal Code
    27513
    Country
    US
    Correspondent
    Marc O Schurr

    US Agent

    Business Name
    Ovesco Endoscopy USA Inc.
    Contact Name
    Geoffrey Yates
    Address
    15300 Weston Parkway, Suite 101
    City
    Cary
    State
    NC
    ZIP
    27513
    Country
    US
    Email
    [email protected]
    Phone
    919 6519449

    Products

    Device Name Product Code
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Hemostatic Metal Clip For The Gi Tract PKL

    Proprietary Names

    stentfix OTSC System Set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device