BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENDOLUMIK

    Reg #: 3026671998 · FEI: 3026671998 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    ENDOLUMIK
    Registration Number
    3026671998
    FEI Number
    3026671998
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    364 Patteson Dr. #293
    City
    Morgantown
    State
    WV
    ZIP
    26505
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240069

    Owner / Operator

    Firm Name
    Endolumik
    Operator Number
    10087525
    Address
    364 Patteson Dr. #293
    City
    Morgantown
    State
    WV
    Postal Code
    26505
    Country
    US
    Correspondent
    Mara McFadden

    Products

    Device Name Product Code
    Bougie, Esophageal, And Gastrointestinal, Gastro-Urology FAT
    Tubes, Gastrointestinal (And Accessories) KNT

    Proprietary Names

    Endolumik GCT M Series Endolumik Gastric Calibration Tube

    Establishment Types

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