BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    IS4000 da Vinci EndoWrist Instruments

    Reg #: 3015224777 · FEI: 3015224777 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Prolinair Asia Limited
    Registration Number
    3015224777
    FEI Number
    3015224777
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    DD129 LOT 3304RP, Ping Ha RD
    City
    Ha Tsuen, Yuen Long, N.T.
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K150284

    Owner / Operator

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

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    IS4000 da Vinci EndoWrist Instruments 8mm Debakey Forceps 8mm Cadiere Forceps 8mm Cobra Grasper 8mm Round Tip Scissor

    Establishment Types

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