Gynecare Innovation Center: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Gynecare Innovation Center” (first 1996, latest 1998), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 119 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 |
|---|---|---|---|
| FJL | Resectoscope | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 1 | 1 |
Review panels
Most recent Gynecare Innovation Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980393 | SOPRANO CRYO-THERAPY SYSTEM | GEI | 1998-05-01 | 88 |
| K971305 | FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM | HIH | 1997-08-11 | 125 |
| K964441 | FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU | KNF | 1997-03-28 | 142 |
| K964892 | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) | FJL | 1997-02-04 | 60 |
| K963872 | FEMRX MORCELLATOR SYSTEM | HET | 1997-01-17 | 113 |
| K962506 | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] | FJL | 1996-09-16 | 81 |
| K954775 | FLO-STAT FLUID MONITORING SYSTEM | HET | 1996-05-10 | 206 |
| K954648 | FEMRX OPERASTAR SYSTEM | HIH | 1996-03-14 | 156 |
Recalls
openFDA lists no recalls under a recalling firm named Gynecare Innovation Center.
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, Inc. (3 510(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 Innovation Center?
FDA lists 8 510(k) clearances under the applicant name “Gynecare Innovation Center” (first 1996, latest 1998), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gynecare Innovation Center?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gynecare Innovation Center is 119 days.
Which FDA product codes appear under Gynecare Innovation Center?
The most frequent FDA product codes under this applicant name are FJL (Resectoscope, 2); HET (Laparoscope, Gynecologic (And Accessories), 2); HIH (Hysteroscope (And Accessories), 2).
Next steps
- See all 8 Gynecare Innovation Center clearances with predicates and recalls
- Run predicate analysis for product code FJL, Gynecare Innovation Center'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.