BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Single-Site Monopolar Cautery , 5mm, da Vinci Si

    Reg #: 3015224777 · FEI: 3015224777 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    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
    K112208

    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

    Single-Site Monopolar Cautery , 5mm, da Vinci Si Single-Site Port for 8.5 mm Endoscope, da Vinci Si da Vinci Single-Site Instruments and Accessories Single-Site Maryland Dissector , 5mm, da Vinci Si Single-Site Bipolar Maryland, 5mm, da Vinci Si da Vinci Single-Site Port Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si Single-Site Starter Kit US, Cholecystectomy, 20 Cases Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si Single-Site Fundus Grasper , 5mm, da Vinci Si Single-Site 10 mm Accessory Cannula, da Vinci Si Single-Site 10 mm Blunt Obturator, da Vinci Si

    Establishment Types

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