BEUDAMED
    FDA Registration Active 🇺🇸 United States

    stentfix OTSC System Set

    Reg #: 3008720584 · FEI: 3008720584 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Ovesco Endoscopy USA
    Registration Number
    3008720584
    FEI Number
    3008720584
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    15300 Weston Parkway, Suite 101
    City
    Cary
    State
    NC
    ZIP
    27513
    Country
    US

    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

    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