Data / Medical devices / Israel / Momentis Surgical Ltd.
Momentis Surgical Ltd.: FDA-registered device maker in Or Yehuda Tel Aviv, Israel, 9 510(k) clearances
Momentis Surgical Ltd. is registered with the FDA (registration 3014155960) in Or Yehuda Tel Aviv, Israel. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014155960
- Address
- 6 Yoni Netanyahu, Or Yehuda Tel Aviv, Israel, 6037604
- Owner or operator
- Momentis Surgical Ltd. (10082179)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 30, 2021
- Registered through
- 2026
- Brand names listed
- Abdominal Access Kit, Access Kit, Anovo Instrument ARM Curved Scissors, Anovo Instrument ARM Hook Electrode, Anovo Sterile Drape for Robotic Control Unit, Anovo Surgical System, Anovo Surgical System 6N, Anovo Surgical System 6Ne and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Modular Electromechanical Surgical System | SCV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mountable Electromechanical Surgical System For Transluminal Approaches | QNM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2026 | K260804 | Anovo Surgical System (6Ne) | SCV | Substantially Equivalent | Momentis Surgical , Ltd. | accessdata.fda.gov |
| July 8, 2025 | K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | QNM | Substantially Equivalent | Momentis Surgical , Ltd. | accessdata.fda.gov |
| June 6, 2025 | K250591 | Anovo Surgical System (6Ne) | QNM | Substantially Equivalent | Momentis Surgical , Ltd. | accessdata.fda.gov |
| May 2, 2025 | K251056 | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | QNM | Substantially Equivalent | Momentis Surgical , Ltd. | accessdata.fda.gov |
| February 3, 2025 | K243182 | Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | QNM | Substantially Equivalent | Momentis Surgical , Ltd. | accessdata.fda.gov |
| October 21, 2024 | K242157 | Anovo Surgical System (Model 6Ne) | QNM | Substantially Equivalent | Momentis Surgical , Ltd. | accessdata.fda.gov |
| October 2, 2024 | K241907 | Anovo Surgical System (model 6N) | QNM | Substantially Equivalent | Momentis Surgical , Ltd. | accessdata.fda.gov |
| September 14, 2023 | K232146 | Anovo Pedestal | QNM | Substantially Equivalent | Momentis Surgical , Ltd. | accessdata.fda.gov |
| February 26, 2021 | DEN190022 | Hominis Surgical System | QNM | Unknown | Momentis Surgical , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.