QKA — Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia Class II

FDA Device Classification

Classification Details

Product Code: QKA
Device Class: Class II
Regulation Number: 876.5510
Submission Type
Review Panel: GU
Medical Specialty: Gastroenterology, Urology
Implant: No

Definition

A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K253525	prodeon medical	Urocross Expander System (Model Numbers ES2018 and ES3025)	March 12, 2026
K210138	medi-tate	iTind System	June 25, 2021
DEN190020	medi-tate	iTind System	February 25, 2020