Momentis Surgical , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Momentis Surgical , Ltd.” (first 2023, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 92 days. Since 2017 the median was 92 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 57 |
| 2024 | 2 | 92 |
| 2025 | 4 | 64 |
| 2026 | 1 | 132 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Momentis Surgical , Ltd. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QNM | Mountable Electromechanical Surgical System For Transluminal Approaches | 8 | 7 |
| SCV | Modular Electromechanical Surgical System | 1 | 1 |
Review panels
Most recent Momentis Surgical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260804 | Anovo Surgical System (6Ne) | SCV | 2026-07-22 | 132 |
| K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | QNM | 2025-07-08 | 29 |
| K250591 | Anovo Surgical System (6Ne) | QNM | 2025-06-06 | 99 |
| K251056 | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | QNM | 2025-05-02 | 28 |
| K243182 | Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | QNM | 2025-02-03 | 126 |
| K242157 | Anovo Surgical System (Model 6Ne) | QNM | 2024-10-21 | 90 |
| K241907 | Anovo Surgical System (model 6N) | QNM | 2024-10-02 | 93 |
| K232146 | Anovo Pedestal | QNM | 2023-09-14 | 57 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190022 | De Novo | Mountable Electromechanical Surgical System For Transluminal Approaches | 2021-02-26 |
Recalls
openFDA lists no recalls under a recalling firm named Momentis Surgical , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Momentis Surgical , Ltd. is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06457971: Anovo Surgical System in Ventral Hernia (Recruiting, started 2024-01-14)
- NCT05945433: Anovo™ Surgical System - Registry Study (Recruiting, started 2023-06-28)
Frequently asked questions
How many FDA 510(k) clearances are listed under Momentis Surgical , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Momentis Surgical , Ltd.” (first 2023, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Momentis Surgical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Momentis Surgical , Ltd. is 92 days. Since 2017: 92 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Momentis Surgical , Ltd.?
The most frequent FDA product codes under this applicant name are QNM (Mountable Electromechanical Surgical System For Transluminal Approaches, 8); SCV (Modular Electromechanical Surgical System, 1).
Next steps
- See all 8 Momentis Surgical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QNM, Momentis Surgical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.