Asensus Surgical, Inc.: FDA clearances and approvals
Asensus Surgical, Inc. has 6 FDA 510(k) clearances (first 2021, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time: 114 days. Since 2017 its median was 114 days, against 104 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Asensus Surgical, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 74 |
| 2022 | 1 | 60 |
| 2023 | 1 | 167 |
| 2024 | 1 | 226 |
| 2025 | 0 | — |
| 2026 | 1 | 140 |
Review time against the same product codes
Since 2017, Asensus Surgical, Inc.'s cleared 510(k)s took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | 6 | 6 |
Review panels
Most recent Asensus Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254192 | Senhance Ultrasonic System | NAY | 2026-05-12 | 140 |
| K233866 | Senhance Surgical System | NAY | 2024-07-19 | 226 |
| K223095 | Senhance Surgical System | NAY | 2023-03-16 | 167 |
| K220889 | Senhance Surgical System | NAY | 2022-05-27 | 60 |
| K212054 | Senhance Surgical System | NAY | 2021-08-30 | 61 |
| K211325 | Senhance Surgical System | NAY | 2021-07-27 | 88 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-09-15.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Asensus Surgical, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07081828: The Asensus Paediatric Robotic Registry (Recruiting, started 2025-06-17)
- NCT03385109: The TransEnterix European Patient Registry (Recruiting, started 2017-07-25)
Frequently asked questions
How many FDA 510(k) clearances does Asensus Surgical, Inc. have?
Asensus Surgical, Inc. has 6 FDA 510(k) clearances (first 2021, latest 2026), across 1 product code in 1 review panel.
How long does FDA take to clear Asensus Surgical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Asensus Surgical, Inc.'s cleared 510(k)s is 114 days. Since 2017: 114 days, versus 104 days for all cleared 510(k)s in the same product codes.
What devices does Asensus Surgical, Inc. make?
Its most frequent FDA product codes are NAY (System, Surgical, Computer Controlled Instrument, 6).
Has Asensus Surgical, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Asensus Surgical, Inc; the most recent began 2023-09-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Asensus Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NAY, Asensus Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.