BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Needle Driver, da Vinci SP

    Reg #: 3015224777 · FEI: 3015224777 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    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
    K182371

    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

    Proprietary Names

    Needle Driver, da Vinci SP Cleaning and Sterilization Kit, da Vinci SP Fenestrated Bipolar Forceps, da Vinci SP Cautery Spatula Tip, da Vinci SP Camera Sheath, da Vinci SP MCS Tip, da Vinci SP da Vinci SP Surgical System, Patient Cart Monopolar Curved Scissors, da Vinci SP da Vinci SP Surgical System Maryland Bipolar Forceps, da Vinci SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP EndoWrist SP Camera, 0 degree, da Vinci SP Medium-Large Clip Applier, da Vinci SP EnergyShield Monopolar Cautery Cord, da Vinci SP Monopolar Cautery Instrument, da Vinci SP Instrument Sheath, da Vinci SP da Vinci SP Surgical System, Surgeon Console EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP Cadiere Forceps, da Vinci SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP da Vinci SP Surgical System, Vision Cart Round Tooth Retractor, da Vinci SP Bipolar Cautery Cord, da Vinci SP Cautery Hook Tip, da Vinci SP OBTURATOR,ONE PIECE,SP1098,25X100MM,REUSABLE CANNULA,SP1098,25X100MM, STANDARD, REUSABLE

    Establishment Types

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