Product code FFA— Gastroenterology, Urology
C-FLEX PENROSE DRAINAGE TUBE
- Classification name
- Tube, Drainage, Suprapubic
- Device class
- Class 2
- Regulation
- 21 CFR 876.5090
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code FFA
FDA has cleared devices under product code FFA between 1983 and 1994, 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
- 1994
- 1987
- 1983
Top applicants under product code FFA
Adverse events under product code FFA
product code FFA- Death
- 3
- Total
- 3
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 FFA
Data sourced from openFDA. This site is unofficial and independent of the FDA.