Gynecare, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Gynecare, Inc.” (first 1996, latest 2000), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 141 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
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 |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | 3 | 3 |
| MNB | Device, Thermal Ablation, Endometrial | 1 | 0 |
Review panels
Most recent Gynecare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992901 | GYNECARE VERSAPOINT G-VAP ELECTRODE | HIH | 2000-01-18 | 141 |
| K982738 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | HIH | 1999-03-01 | 207 |
| K962482 | SCUBA SYSTEM | HIH | 1996-11-01 | 128 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970021 | PMA | THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM | 1997-12-12 |
Recalls
openFDA lists no recalls under a recalling firm named Gynecare, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Gynecare Innovation Center (8 510(k)s)
- Gynecare, A Div. of Ethicon, Inc. (2 510(k)s)
- Gynecare Center (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gynecare, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Gynecare, Inc.” (first 1996, latest 2000), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gynecare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gynecare, Inc. is 141 days.
Which FDA product codes appear under Gynecare, Inc.?
The most frequent FDA product codes under this applicant name are HIH (Hysteroscope (And Accessories), 3); MNB (Device, Thermal Ablation, Endometrial, 1).
Next steps
- See all 3 Gynecare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIH, Gynecare, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.