DeviceClearance

Product code QKA— Gastroenterology, Urology

iTind System

Classification name
Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Device class
Class 2
Regulation
21 CFR 876.5510
Advisory panel
Gastroenterology, Urology
Total cleared
4
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QKA under 21 CFR 876.5510, via openFDA

Market context for product code QKA

FDA has cleared 4 devices under product code QKA between 2020 and 2026, filed by 2 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

Top applicants under product code QKA

Recent clearances under product code QKA

Data sourced from openFDA. This site is unofficial and independent of the FDA.