FDA product code SCV: Modular Electromechanical Surgical System
SCV is the FDA product code for modular electromechanical surgical system. It is a Class II device, regulated under 21 CFR 878.4964 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under SCV, 3 in the last five years, from 3 different applicants. The average 510(k) review took 187 days (median 162); 174 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for SCV devices, 1 initiated in the last five years.
Definition
A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.
Classification
| Field | Value |
|---|---|
| Device name | Modular Electromechanical Surgical System |
| Device class | Class II |
| Regulation | 21 CFR 878.4964 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for SCV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 2 | 215 |
| 2026 | 1 | 132 |
Compare with all 510(k) review times · Search every SCV clearance
Top SCV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Momentis Surgical , Ltd. | 1 | 2026-07-22 |
| Cmr Surgical Limited | 1 | 2025-12-16 |
| Covidien, LLC | 1 | 2025-12-03 |
Most recent SCV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260804 | Momentis Surgical , Ltd. | Anovo Surgical System (6Ne) | 2026-07-22 | 132 |
| K252111 | Cmr Surgical Limited | Versius Surgical System (Versius Plus) | 2025-12-16 | 162 |
| K250725 | Covidien, LLC | Hugo RAS System | 2025-12-03 | 268 |
Recalls for SCV devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-06-09.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code SCV?
SCV is the FDA product code for modular electromechanical surgical system. It is a Class II device, regulated under 21 CFR 878.4964 and reviewed by the General and Plastic Surgery panel.
What device class is SCV?
Class II, regulation 21 CFR 878.4964. Typical premarket route: 510(k).
How long does a 510(k) take for product code SCV?
Across 3 cleared submissions the average was 187 days from receipt to decision (median 162).
Which companies have the most SCV clearances?
Momentis Surgical , Ltd. (1); Cmr Surgical Limited (1); Covidien, LLC (1).
Have SCV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-06-09.
Next steps
- Run an FDA pathway report with predicate devices for product code SCV
- Run a recall and safety report across every SCV manufacturer
- Watch product code SCV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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