Product code FKA— Gastroenterology, Urology
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
- Classification name
- Dilator, Vessel
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code FKA
FDA has cleared devices under product code FKA between 1991 and 2002, 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
- 2002
- 1993
- 1991
Top applicants under product code FKA
Recent clearances under product code FKA
Data sourced from openFDA. This site is unofficial and independent of the FDA.