BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    colonic FTRD Set

    Reg #: 3006696607 · FEI: 3006696607 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    4

    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
    K170867

    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
    Hemostatic Metal Clip For The Gi Tract PKL
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Snare, Flexible FDI

    Proprietary Names

    colonic FTRD Set FTRD System Set diagnostic FTRD Set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device