BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Enseal X1 Large Jaw Tissue Sealer

    Reg #: 9710649 · FEI: 3003565435 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II
    Registration Number
    9710649
    FEI Number
    3003565435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CALLE DURANGO No. 2751, COLONIA LOTE BRAVO
    City
    CIUDAD JUAREZ Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K163548

    Owner / Operator

    Firm Name
    ETHICON ENDO-SURGERY, INC.
    Operator Number
    9010225
    Address
    4545 CREEK RD., ML #39
    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
    Instrument, Ultrasonic Surgical LFL

    Proprietary Names

    Enseal X1 Large Jaw Tissue Sealer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)