BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SP Round Tooth Retractor Extended Range

    Reg #: 3015612252 · FEI: 3015612252 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    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
    K241814

    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

    SP Round Tooth Retractor Extended Range SP Maryland Bipolar Forceps SP Cadiere Forceps SP Monopolar Cautery Instrument SP Needle Driver Extended Range SP Force Bipolar SP Cadiere Forceps, Extended Range SP Needle Driver SP Force Bipolar, Extended Range SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments) SP Monopolar Curved Scissors Extended Range SP Monopolar Curved Scissors SP Fenestrated Bipolar Forceps SP Medium Large Clip Applier SP Maryland Bipolar Forceps, Extended Range

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198