BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    OVESCO ENDOSCOPY AG

    Reg #: 3006696607 · FEI: 3006696607 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    38
    Establishment Types
    3
    Classifications
    16

    Registration Details

    Registration Name
    OVESCO ENDOSCOPY AG
    Registration Number
    3006696607
    FEI Number
    3006696607
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Friedrich-Miescher-Strasse 9
    City
    Tuebingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K140923

    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
    Snare, Flexible FDI
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Hemostatic Metal Clip For The Gi Tract PKL
    Guide, Surgical, Instrument FZX
    Instrument, Manual, Surgical, General Use MDM
    Submucosal Injection Agent PLL
    Forceps, Biopsy, Electric KGE
    Endoscopic Electrosurgical Clip Cutting System QAG
    Guillotine, Tonsil KBO
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Instrument, Special Lens, For Endoscope FEI
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Endoscopic Irrigation/Suction System OCX
    Dilator, Esophageal KNQ
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS

    Proprietary Names

    Traction Polypectomy Snare diagnostic FTRD Set colonic FTRD Set FTRD System Set OTSC®neo System Set (1001n-14n, 100.27n-31n) AWC AWCduo Fistula Brush LiftUp LiftUp Kit mini OTSC System Set OTSC System Set Coag Endo-Dissector Coag Dissector remOVE DC Cutter Set remOVE DC Impulse DIMEDA gastroduodenal FTRD Set stentfix OTSC System Set AqaNife colonic FTRD prOVE Cap gastroduodenal FTRD prOVE Cap remOVE FBR Set FTRD Grasper Set OTSG Xcavator ArgoCap OTSC Proctology BARS Set (100.60) BougieCap Set BougieCap BougieCap P OTSC Proctology Anchor OTSC Anchor 165 BARS Anchor black OTSC Twin Grasper 165 BARS Anchor silver OTSC Twin Grasper 220 OTSC Anchor 220tt

    Establishment Types

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