Product code FGC— Gastroenterology, Urology
DIRECTVISION GUIDE SYSTEM
- Classification name
- Urethroscope
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code FGC
FDA has cleared devices under product code FGC between 1980 and 2009, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2009
- 1995
- 1980
Top applicants under product code FGC
Adverse events under product code FGC
product code FGC- Malfunction
- 1,686
- Total
- 1,686
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FGC
Data sourced from openFDA. This site is unofficial and independent of the FDA.