Product code FFH— Gastroenterology, Urology
INTECARE PEDIATRIC URINE COLLECTOR
- Classification name
- Collector, Urine, Pediatric, For Indwelling Catheter
- Device class
- Class 2
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code FFH
FDA has cleared devices under product code FFH between 1987 and 1990, 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
- 1990
- 1987
Top applicants under product code FFH
Recent clearances under product code FFH
Data sourced from openFDA. This site is unofficial and independent of the FDA.