QXB — Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia Class III

FDA Device Classification

FDA product code QXB covers "Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia", a Class III medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
QXB
Device Class
Class III
Regulation Number
Submission Type
Review Panel
GU
Medical Specialty
Unknown
Implant
No

Definition

dilate prostatic urethra to treat obstructive urinary symptoms associated with benign prostatic hyperplasia