Circon Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Circon Corp.” (first 1997, latest 1999), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| FAS | Electrode, Electrosurgical, Active, Urological | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| HEW | Culdoscope (And Accessories) | 1 | 1 |
| HEX | Colposcope (And Colpomicroscope) | 1 | 1 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 1 | 1 |
| KNY | Accessories, Catheter, G-U | 1 | 1 |
Review panels
Most recent Circon Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992544 | TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM | HEX | 1999-10-26 | 88 |
| K992126 | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | GCX | 1999-08-03 | 41 |
| K981611 | SNAP-N-PEEL INTRODUCERS | KNY | 1998-07-30 | 85 |
| K980972 | RIGID CULDOSCOPE AND ACCESSORIES | HEW | 1998-06-12 | 88 |
| K973820 | USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE | FAS | 1998-05-12 | 217 |
| K964594 | VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) | KNF | 1997-08-15 | 273 |
Recalls
openFDA lists no recalls under a recalling firm named Circon Corp..
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.
- Circon Video (14 510(k)s)
- Circon Acmi (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Circon Corp.?
FDA lists 6 510(k) clearances under the applicant name “Circon Corp.” (first 1997, latest 1999), across 6 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 Circon Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Circon Corp. is 88 days.
Which FDA product codes appear under Circon Corp.?
The most frequent FDA product codes under this applicant name are FAS (Electrode, Electrosurgical, Active, Urological, 1); GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 1); HEW (Culdoscope (And Accessories), 1).
Next steps
- See all 6 Circon Corp. clearances with predicates and recalls
- Run predicate analysis for product code FAS, Circon Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.