BEUDAMED
    FDA Registration Active 🇪🇨 Ecuador

    Alignment Target, 8.6mm Endoscope

    Reg #: 3014635169 · FEI: 3014635169 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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
    K080155

    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
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Alignment Target, 8.6mm Endoscope 8.5mm Endoscope, 0° Cannula, 8.5mm Endoscope 8.5mm Endoscope, 30°

    Establishment Types

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