Circon Video: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Circon Video” (first 1990, latest 2002), across 11 product codes in 3 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 |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 4 | 4 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FCW | Light Source, Fiberoptic, Routine | 1 | 1 |
| FEN | Device, Cystometric, Hydraulic | 1 | 1 |
| FFK | Lithotriptor, Electro-Hydraulic | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| HIG | Insufflator, Hysteroscopic | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Circon Video 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012758 | URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, | FGB | 2002-04-09 | 235 |
| K011876 | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 | HIG | 2002-01-08 | 207 |
| K011849 | MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS | FGB | 2001-12-10 | 180 |
| K012929 | FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 | FAJ | 2001-11-19 | 80 |
| K012951 | APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE | FGB | 2001-11-09 | 66 |
| K012925 | DUR-8, MODELS DUR-8 | FGB | 2001-11-07 | 68 |
| K012265 | METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 | FCW | 2001-10-17 | 90 |
| K012153 | LOWSLEY SUPRAPUBIC TRACTOR | KOB | 2001-09-19 | 70 |
| K011848 | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE | FFK | 2001-09-11 | 90 |
| K970595 | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP | FEN | 1997-10-24 | 248 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Circon Video.
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 Acmi (10 510(k)s)
- Circon Corp. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Circon Video?
FDA lists 14 510(k) clearances under the applicant name “Circon Video” (first 1990, latest 2002), across 11 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 Video?
The median time from FDA receipt to decision across 510(k)s cleared under the name Circon Video is 90 days.
Which FDA product codes appear under Circon Video?
The most frequent FDA product codes under this applicant name are FGB (Ureteroscope And Accessories, Flexible/Rigid, 4); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1); FCW (Light Source, Fiberoptic, Routine, 1).
Next steps
- See all 14 Circon Video clearances with predicates and recalls
- Run predicate analysis for product code FGB, Circon Video'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.