Axcan Scientific Corp.: FDA clearances and approvals
Axcan Scientific Corp. has 5 FDA 510(k) clearances (first 1982, latest 1984), across 4 product codes in 1 review panel. Median 510(k) review time: 106 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HFF | Aspirator, Endometrial | 2 | 2 |
| HDR | Cap, Cervical | 1 | 1 |
| HHM | Sound, Uterine | 1 | 1 |
| HIG | Insufflator, Hysteroscopic | 1 | 1 |
Review panels
Most recent Axcan Scientific Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842943 | AXCAN UTERINE SUCCION INJECTOR | HIG | 1984-09-21 | 58 |
| K831212 | ENDOSCANN | HFF | 1984-06-15 | 428 |
| K831224 | AUGROS HYSTEROMETER | HHM | 1983-10-28 | 196 |
| K831669 | AXCAN SPERM CUP | HDR | 1983-07-12 | 50 |
| K820641 | ACCURETTE | HFF | 1982-06-22 | 106 |
Recalls
openFDA lists no recalls under a recalling firm named Axcan Scientific Corp..
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 Axcan Scientific Corp. have?
Axcan Scientific Corp. has 5 FDA 510(k) clearances (first 1982, latest 1984), across 4 product codes in 1 review panel.
How long does FDA take to clear Axcan Scientific Corp.'s 510(k)s?
The median time from FDA receipt to decision across Axcan Scientific Corp.'s cleared 510(k)s is 106 days.
What devices does Axcan Scientific Corp. make?
Its most frequent FDA product codes are HFF (Aspirator, Endometrial, 2); HDR (Cap, Cervical, 1); HHM (Sound, Uterine, 1).
Has Axcan Scientific Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Axcan Scientific Corp. Related entities may recall under other names.
Next steps
- See all 5 Axcan Scientific Corp. clearances with predicates and recalls
- Run predicate analysis for product code HFF, Axcan Scientific Corp.'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.