Gynescope Corp.: FDA clearances and approvals
Gynescope Corp. has 9 FDA 510(k) clearances (first 1990, latest 1990), across 6 product codes in 2 review panels. Median 510(k) review time: 70 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 4 | 4 |
| EJT | Alloy, Gold-Based Noble Metal | 1 | 1 |
| HDF | Speculum, Vaginal, Metal | 1 | 1 |
| HFB | Forceps, Biopsy, Gynecological | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 1 | 1 |
Review panels
- Obstetrics and Gynecology (8)
- Dental (1)
Most recent Gynescope Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902658 | GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES | KNF | 1990-09-19 | 96 |
| K902657 | GYNESCOPE LAPAROSCOPIC FORCEPS | HET | 1990-09-19 | 96 |
| K901530 | WALLACE INTRAUTERINE INSEMINATION CATHETER | EJT | 1990-07-23 | 112 |
| K902655 | GYNESCOPE LAPAROSCOPES | HET | 1990-07-13 | 28 |
| K902656 | GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES | HET | 1990-06-29 | 14 |
| K902049 | CROAK OVARIAN BIOPSY FORCEP | HFB | 1990-06-07 | 31 |
| K902019 | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS | HDF | 1990-06-07 | 35 |
| K900878 | OTT INSUFFLATION FILTER TUBING | HIF | 1990-05-07 | 70 |
| K895225 | GYNECOLOGICAL INSTRUMENTATION | HET | 1990-03-05 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named Gynescope 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 Gynescope Corp. have?
Gynescope Corp. has 9 FDA 510(k) clearances (first 1990, latest 1990), across 6 product codes in 2 review panels.
How long does FDA take to clear Gynescope Corp.'s 510(k)s?
The median time from FDA receipt to decision across Gynescope Corp.'s cleared 510(k)s is 70 days.
What devices does Gynescope Corp. make?
Its most frequent FDA product codes are HET (Laparoscope, Gynecologic (And Accessories), 4); EJT (Alloy, Gold-Based Noble Metal, 1); HDF (Speculum, Vaginal, Metal, 1).
Has Gynescope Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Gynescope Corp. Related entities may recall under other names.
Next steps
- See all 9 Gynescope Corp. clearances with predicates and recalls
- Run predicate analysis for product code HET, Gynescope 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.