Gynex Corp.: FDA clearances and approvals
Gynex Corp. has 5 FDA 510(k) clearances (first 1998, latest 2006), across 5 product codes in 1 review panel. Median 510(k) review time: 89 days. openFDA lists 1 product recall by a recalling firm named Gynex Corp.
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 |
|---|---|---|---|
| HDC | Tenaculum, Uterine | 1 | 1 |
| HEE | Set, Anesthesia, Paracervical | 1 | 1 |
| HEX | Colposcope (And Colpomicroscope) | 1 | 1 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
Review panels
Most recent Gynex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061306 | CO-1000 COLPOSCOPE, MULTIPLE | HEX | 2006-08-07 | 89 |
| K982739 | GYNEX ELECTRODES | HGI | 1999-03-12 | 218 |
| K980238 | GYNEX EXTENDED REACH NEEDLE | HEE | 1998-08-21 | 210 |
| K980237 | GYNEX ENDOSPECULUM | KNA | 1998-04-08 | 75 |
| K980247 | GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM | HDC | 1998-03-17 | 53 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-09-06.
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 Gynex Corp. have?
Gynex Corp. has 5 FDA 510(k) clearances (first 1998, latest 2006), across 5 product codes in 1 review panel.
How long does FDA take to clear Gynex Corp.'s 510(k)s?
The median time from FDA receipt to decision across Gynex Corp.'s cleared 510(k)s is 89 days.
What devices does Gynex Corp. make?
Its most frequent FDA product codes are HDC (Tenaculum, Uterine, 1); HEE (Set, Anesthesia, Paracervical, 1); HEX (Colposcope (And Colpomicroscope), 1).
Has Gynex Corp. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Gynex Corp; the most recent began 2012-09-06. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Gynex Corp. clearances with predicates and recalls
- Run predicate analysis for product code HDC, Gynex 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.