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    FDA Registration Active 🇺🇸 United States

    Ovesco Endoscopy USA

    Reg #: 3008720584 · FEI: 3008720584 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    38
    Establishment Types
    2
    Classifications
    16

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    Registration Details

    Registration Name
    Ovesco Endoscopy USA
    Registration Number
    3008720584
    FEI Number
    3008720584
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    15300 Weston Parkway, Suite 101
    City
    Cary
    State
    NC
    ZIP
    27513
    Country
    US

    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

    Products

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

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device