BEUDAMED
    FDA Registration Active 🇪🇨 Ecuador

    Harmonic Ace Curved Shears

    Reg #: 3014635169 · FEI: 3014635169 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ALEM
    Registration Number
    3014635169
    FEI Number
    3014635169
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Vicente Duque N77-57, y Antonio Castillo
    City
    Quito Pichincha
    Country
    EC

    Regulatory Submissions

    510(k) Number
    K093217

    Owner / Operator

    Firm Name
    Intuitive Surgical, Inc.
    Operator Number
    9028901
    Address
    1266 Kifer Road, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94086
    Country
    US

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    Harmonic Ace Curved Shears Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000) Harmonic Ace Curved Shears , 5mm, da Vinci S, Si Harmonic Ace Curved Shears , 8mm, da Vinci S, Si Harmonic Ace Curved Shears , 5mm, da Vinci

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device