BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Monopolar Cautery Instrument, da Vinci SP

    Reg #: 3015612252 · FEI: 3015612252 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INTUITIVE SURGICAL, INC.
    Registration Number
    3015612252
    FEI Number
    3015612252
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3410 Central Expressway, --
    City
    Santa Clara
    State
    CA
    ZIP
    95051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211595

    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

    Monopolar Cautery Instrument, da Vinci SP SP Access Port Kit, Large Incision (2.7 cm-7 cm) MCS Tip, da Vinci SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP Cautery Hook Tip, da Vinci SP da Vinci SP Surgical System, Patient Cart da Vinci SP Surgical System Bipolar Cautery Cord, da Vinci SP Instrument Sheath, da Vinci SP Fenestrated Bipolar Forceps, da Vinci SP Medium-Large Clip Applier, da Vinci SP SP Access Port Kit, Small Incision (2.7 cm-4 cm) EnergyShield Monopolar Cautery Cord, da Vinci SP da Vinci SP Surgical System, Surgeon Console Round Tooth Retractor, da Vinci SP Monopolar Curved Scissors, da Vinci SP Cleaning and Sterilization Kit, da Vinci SP Needle Driver, da Vinci SP Camera Sheath, da Vinci SP Cautery Spatula Tip, da Vinci SP da Vinci SP Surgical System, Vision Cart Maryland Bipolar Forceps, da Vinci SP Instrument Arm Drape, da Vinci SP Cadiere Forceps, da Vinci SP EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP EndoWrist SP Camera, 0 degree, da Vinci SP

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198