FDA device listing
Access Kit,Anovo Surgical System Model 6Ne,Instrument ARM Curved Scissors,Instrument ARM Grasper,Instrument ARM Hook…
FDA device listing 1307389319 · Momentis Surgical Ltd.
Key facts
| Proprietary names | Access Kit,Anovo Surgical System Model 6Ne,Instrument ARM Curved Scissors,Instrument ARM Grasper,Instrument ARM Hook Electrode,Multi-port Pedestal,Pedal Energy Cable,Pedestal,Robotic Control Unit 6Ne,Surgeon Console 6Ne,Unit Cable,Vaginal Access Kit |
|---|---|
| Owner/operator | Momentis Surgical Ltd. |
| Owner/operator number | 10082179 |
| Premarket submissions | K260804 |
| Product codes | SCV |
| Device names | SCV - Modular Electromechanical Surgical System |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4964 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Momentis Surgical Ltd. |
| Establishment registrations | 3014155960 |
| FEI numbers | 3014155960 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database