BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Momentis Surgical Ltd.

    Reg #: 3014155960 · FEI: 3014155960 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    27
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Momentis Surgical Ltd.
    Registration Number
    3014155960
    FEI Number
    3014155960
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 Yoni Netanyahu
    City
    Or Yehuda Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K232146

    Owner / Operator

    Firm Name
    Momentis Surgical Ltd.
    Operator Number
    10082179
    Address
    6 Yoni Netanyahu
    City
    Or Yehuda
    State
    Tel Aviv
    Postal Code
    6037604
    Country
    IL
    Correspondent
    Maya Leib Shlomo

    US Agent

    Business Name
    MedicSense USA LLC
    Contact Name
    George Hattub
    Address
    291 Hillside Avenue
    City
    Somerset
    State
    MA
    ZIP
    02726
    Country
    US
    Email
    [email protected]
    Phone
    508 4796116

    Products

    Device Name Product Code
    Mountable Electromechanical Surgical System For Transluminal Approaches QNM
    Drape, Surgical, Exempt PUI

    Proprietary Names

    Instrument ARM Curved Scissors Pedestal Pedal Energy Cable Access Kit Anovo Surgical System 6Ne Robotic Control Unit 6Ne Surgeon Console 6Ne Instrument ARM Grasper Unit Cable Instrument ARM Hook Electrode Anovo Instrument ARM Hook Electrode Anovo Instrument ARM Curved Scissors Vaginal Access Kit Instrument ARM Robotic Control Unit 6N Anovo Surgical System 6N Abdominal Access Kit Surgeon Console 6N Sterile Drape for Robotic Control Unit, Bottom Sterile Drape for Robotic Control Unit, Top Anovo Sterile Drape for Robotic Control Unit Unit Cables Robotic Control Unit Support System Robotic Control Unit Surgeon Console Anovo Surgical System Instrument ARMS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility