Circon Video: FDA clearances and approvals
Circon Video has 14 FDA 510(k) clearances (first 1990, latest 2002), across 11 product codes in 3 review panels. Median 510(k) review time: 90 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Circon Video have?
Circon Video has 14 FDA 510(k) clearances (first 1990, latest 2002), across 11 product codes in 3 review panels.
How long does FDA take to clear Circon Video's 510(k)s?
The median time from FDA receipt to decision across Circon Video's cleared 510(k)s is 90 days.
What devices does Circon Video make?
Its most frequent FDA product codes are FGB (Ureteroscope And Accessories, Flexible/Rigid, 4); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1); FCW (Light Source, Fiberoptic, Routine, 1).
Has Circon Video had device recalls?
openFDA lists no recalls under a recalling firm name matching Circon Video. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.