Alesi Surgical, Ltd.: FDA clearances and approvals
Alesi Surgical, Ltd. has 5 FDA 510(k) clearances (first 2017, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 127 days. Since 2017 its median was 127 days, against 132 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 127 |
| 2018 | 1 | 38 |
| 2019 | 0 | — |
| 2020 | 1 | 117 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 183 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Alesi Surgical, Ltd.'s cleared 510(k)s took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQM | Surgical Smoke Precipitator | 6 | 5 |
Review panels
- General Hospital (6)
Most recent Alesi Surgical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231298 | Ultravision2 System Integrated Monopolar L-Hook (H/S) | PQM | 2023-10-31 | 180 |
| K231238 | Ultravision2 System | PQM | 2023-10-31 | 186 |
| K200035 | Ultravision Visual Field Clearing System | PQM | 2020-05-04 | 117 |
| K182053 | Ultravision Visual Field Clearing System | PQM | 2018-09-07 | 38 |
| K170178 | Ultravision Visual Field Clearing System | PQM | 2017-05-26 | 127 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150022 | De Novo | Surgical Smoke Precipitator | 2016-12-20 |
Recalls
openFDA lists no recalls under a recalling firm named Alesi Surgical, Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances does Alesi Surgical, Ltd. have?
Alesi Surgical, Ltd. has 5 FDA 510(k) clearances (first 2017, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Alesi Surgical, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Alesi Surgical, Ltd.'s cleared 510(k)s is 127 days. Since 2017: 127 days, versus 132 days for all cleared 510(k)s in the same product codes.
What devices does Alesi Surgical, Ltd. make?
Its most frequent FDA product codes are PQM (Surgical Smoke Precipitator, 6).
Has Alesi Surgical, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Alesi Surgical, Ltd. Related entities may recall under other names.
Next steps
- See all 5 Alesi Surgical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PQM, Alesi Surgical, Ltd.'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.