Ovamed Corp.: FDA clearances and approvals
Ovamed Corp. has 5 FDA 510(k) clearances (first 1995, latest 1995), across 4 product codes in 2 review panels. Median 510(k) review time: 697 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | 2 | 2 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
| MOV | Catheters, Salpingography | 1 | 1 |
| ODF | Mini Endoscope, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Ovamed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951946 | HYSTEROSYS FLEXIBLE HYSTEROCOPE | HIH | 1995-11-20 | 208 |
| K931534 | OVAMED INTRAUTERINE ACCESS CATHETER | MOV | 1995-07-28 | 851 |
| K931167 | OVAMED FALLOPIAN OSTIAL ACCESS CATHETER | LKF | 1995-06-22 | 836 |
| K943593 | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM | ODF | 1995-03-22 | 240 |
| K931122 | OVAMED HSG CATHETER | LKF | 1995-01-30 | 697 |
Recalls
openFDA lists no recalls under a recalling firm named Ovamed 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 Ovamed Corp. have?
Ovamed Corp. has 5 FDA 510(k) clearances (first 1995, latest 1995), across 4 product codes in 2 review panels.
How long does FDA take to clear Ovamed Corp.'s 510(k)s?
The median time from FDA receipt to decision across Ovamed Corp.'s cleared 510(k)s is 697 days.
What devices does Ovamed Corp. make?
Its most frequent FDA product codes are LKF (Cannula, Manipulator/Injector, Uterine, 2); HIH (Hysteroscope (And Accessories), 1); MOV (Catheters, Salpingography, 1).
Has Ovamed Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ovamed Corp. Related entities may recall under other names.
Next steps
- See all 5 Ovamed Corp. clearances with predicates and recalls
- Run predicate analysis for product code LKF, Ovamed 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.