Product code FKL— Gastroenterology, Urology
PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT
- Classification name
- Insert, Pump, Blood
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code FKL
FDA has cleared device under product code FKL, all in 1985, filed by 1 applicant company. 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.
Top applicants under product code FKL
Recent clearances under product code FKL
Data sourced from openFDA. This site is unofficial and independent of the FDA.