Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014155960

FEI Number

3014155960

Entity Name

Momentis Surgical Ltd.

City/State/Country

Or Yehuda Tel Aviv, IL

Establishment Address

6 Yoni Netanyahu, Or Yehuda Tel Aviv 6037604, IL

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Momentis Surgical Ltd. (Owner Number: 10082179)

Owner / Operator Contact Address

6 Yoni Netanyahu, Or Yehuda, IL-TA 6037604, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242157

PMA Number

N/A

All Registered 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 Robotic Control Unit 6Ne Unit Cable Anovo Surgical System 6Ne Vaginal Access Kit Pedal Energy Cable Pedestal Surgeon Console 6Ne Instrument ARM Unit Cable Robotic Control Unit 6N Pedestal Instrument ARM 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 Anovo Instrument ARM Curved Scissors Anovo Instrument ARM Hook Electrode Unit Cables Robotic Control Unit Support System Robotic Control Unit Surgeon Console Anovo Surgical System Instrument ARMS Vaginal Access Kit Unit Cable Instrument ARM Anovo Surgical System 6Ne Pedestal Vaginal Access Kit Robotic Control Unit 6Ne Surgeon Console 6Ne Pedal Energy Cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	Class 2	878.4961	2023-12-25
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	Class 2	878.4961	2025-08-27
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	Class 2	878.4961	2025-05-20
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	Class 2	878.4961	2025-06-18
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	Class 2	878.4961	2024-12-04
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-02-14
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	Class 2	878.4961	2025-03-17
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	Class 2	878.4961	2021-06-30
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	Class 2	878.4961	2024-12-04

Official Correspondent

Maya Leib Shlomo

US Agent Details

George Hattub Business: MedicSense USA LLC Email: ghattub@comcast.net Phone: (508) 4796116

Related Public Records

Same Entity

Momentis Surgical Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014155960. Last updated year: 2026. Please use registration number 3014155960 when referencing this establishment in official correspondence.