Surgimed Corp.: FDA clearances and approvals
Surgimed Corp. has 6 FDA 510(k) clearances (first 1981, latest 2007), across 5 product codes in 3 review panels. Median 510(k) review time: 124 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| GES | Blade, Scalpel | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Surgimed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062753 | FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC | FMF | 2007-02-08 | 147 |
| K851157 | SURGIMED - SURGICAL BLADES | GES | 1985-04-25 | 34 |
| K840762 | SILVERTORQUE CEREBRAL CATHETER | DQY | 1984-07-13 | 141 |
| K840763 | SILVERTORQUE CARDIAC CATHETERS | DQO | 1984-06-13 | 111 |
| K840761 | SILVERTORQUE VISCERAL CATHETER | DQY | 1984-06-11 | 109 |
| K810689 | BALLOON CATHETER | — | 1981-07-28 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named Surgimed 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 Surgimed Corp. have?
Surgimed Corp. has 6 FDA 510(k) clearances (first 1981, latest 2007), across 5 product codes in 3 review panels.
How long does FDA take to clear Surgimed Corp.'s 510(k)s?
The median time from FDA receipt to decision across Surgimed Corp.'s cleared 510(k)s is 124 days.
What devices does Surgimed Corp. make?
Its most frequent FDA product codes are DQY (Catheter, Percutaneous, 2); DQO (Catheter, Intravascular, Diagnostic, 1); FMF (Syringe, Piston, 1).
Has Surgimed Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgimed Corp. Related entities may recall under other names.
Next steps
- See all 6 Surgimed Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Surgimed 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.