BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating

    Reg #: 3005075853 · FEI: 3005075853 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ETHICON ENDO-SURGERY, LLC
    Registration Number
    3005075853
    FEI Number
    3005075853
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    475 CALLE C
    City
    GUAYNABO
    State
    PR
    ZIP
    00969
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180403

    Owner / Operator

    Firm Name
    ETHICON ENDO-SURGERY, LLC
    Operator Number
    9071406
    Address
    4545 Creek Rd
    City
    Cincinnati
    State
    OH
    Postal Code
    45242
    Country
    US
    Correspondent
    Emily Nesbitt

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Electrocautery, Gynecologic (And Accessories) HGI

    Proprietary Names

    ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility