FKF — Gun, Tie, Dialysis Class I

FDA Device Classification

FDA product code FKF covers "Gun, Tie, Dialysis", a Class I medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code
FKF
Device Class
Class I
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No