BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    EndoWrist Stapler 30 System

    Reg #: 3008309062 · FEI: 3008309062 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Device Technologies Australia PTY LTD
    Registration Number
    3008309062
    FEI Number
    3008309062
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    47 Arrenway Drive,
    City
    Albany Auckland
    Country
    NZ

    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
    Mario Lowe

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Staple, Implantable GDW
    Stapler, Surgical GAG

    Proprietary Names

    EndoWrist Stapler 30 System EndoWrist Stapler 45 System 8 mm SureForm 30 System SureForm 60 System SureForm 45 System

    Establishment Types

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