BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FUSION OMNI PRE-LOADED WITH ACROBAT 2 WIRE GUIDE

    Reg #: 1037905 · FEI: 1037905 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Wilson-Cook Medical Inc.
    Registration Number
    1037905
    FEI Number
    1037905
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4900 Bethania Station Rd
    City
    Winston Salem
    State
    NC
    ZIP
    27105
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172288

    Owner / Operator

    Firm Name
    COOK ENDOSCOPY
    Operator Number
    9025083
    Address
    4900 BETHANIA STATION RD. &, 5951 GRASSY CREEK BLVD.
    City
    Winston Salem
    State
    NC
    Postal Code
    27105
    Country
    US
    Correspondent
    BRIAN - RUCKER

    Products

    Device Name Product Code
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS

    Proprietary Names

    FUSION OMNI PRE-LOADED WITH ACROBAT 2 WIRE GUIDE FUSION OMNI PRE-LOADED WITH ACROBAT WIRE GUIDE FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME FUSION OMNI-TOME FUSION PRE-LOADED OMNI-TOME FUSION OMNI-TOME SPHINCTEROTOME

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device