BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Intuitive Surgical, S. de R.L. de C.V.

    Reg #: 3007084728 · FEI: 3007084728 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    Intuitive Surgical, S. de R.L. de C.V.
    Registration Number
    3007084728
    FEI Number
    3007084728
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Circuito Internacional Sur #21-A, Parque Industrial Nelson, Carretera a San Luis R.C., Km 14
    City
    Mexicali Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K222839

    Owner / Operator

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

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Staple, Implantable GDW
    Stapler, Surgical GAG
    Bronchoscope (Flexible Or Rigid) EOQ
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    EndoWrist Stapler 45 System 8 mm SureForm 30 System SureForm 45 System SureForm 60 System EndoWrist Stapler 30 System Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) Ion™ Fully Articulating Catheter Ion™ Peripheral Vision Probe da Vinci Xi 12-8 mm Reducer 8 mm Bladeless Obturator (Optical) 8 mm Bladeless Obturator (Optical), Long 8 mm Trocar, Long 5 mm to 8 mm Cannula Seal 8 mm Trocar, Standard Stapler-8mm Cannula Reducer EndoWrist® Stapler 45 Stapler Cannula Blunt Obturator Stapler 45 Reload, White Stapler 45 Reload, Green Stapler Cannula, Long Stapler Cannula Blunt Obturator, Long Stapler 45 Reload, Blue Stapler Cannula Stapler Release Kit Stapler Sheath 10-12mm+Stapler Cannula Seal EndoWrist® Stapler 45 Curved-Tip EndoWrist Stapler System Starter Kit - 45 mm SRK,ENGLISH,IS4000 EndoWrist Stapler Cannula Kit EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm

    Establishment Types

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