Conway Stuart Medical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Conway Stuart Medical, Inc.” (first 1998, latest 2000), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 8 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Conway Stuart Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000245 | CSM STRETTA SYSTEM | GEI | 2000-04-18 | 82 |
| K000170 | SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000 | GEI | 2000-02-14 | 27 |
| K992542 | TUBULAR ELECTRODE DEVICE | GEI | 1999-10-27 | 89 |
| K991529 | CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 | GEI | 1999-09-14 | 134 |
| K990724 | CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES | GCJ | 1999-08-13 | 161 |
| K991291 | STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION | GEI | 1999-07-14 | 90 |
| K983986 | CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR | GEI | 1999-03-23 | 134 |
| K983116 | ELECTROSURGICAL INFLATABLE BASKET ELECTRODES | GEI | 1998-12-03 | 90 |
| K983415 | DELIVERY SHEATH | FED | 1998-12-01 | 63 |
| K981589 | ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES | GEI | 1998-07-30 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Conway Stuart Medical, 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.
- Conway Electronic Enterprises , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Conway Stuart Medical, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Conway Stuart Medical, Inc.” (first 1998, latest 2000), across 3 product codes in 2 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 Conway Stuart Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Conway Stuart Medical, Inc. is 90 days.
Which FDA product codes appear under Conway Stuart Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 8); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 10 Conway Stuart Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Conway Stuart Medical, 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.