QKAClass II
Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Gastroenterology, Urology · 21 CFR 876.5510
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.
MDR events16All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances4All time
Recent MDR events
16 adverse event reports on file
- iTind SystemJul 28, 2026InjuryMedi-tate Ltd.3016677053-2026-00009
- iTind, with snare, sterileJul 28, 2026InjuryMedi-tate Ltd.2429304-2026-00103
- ITIND, WITH SNARE, STERILEMay 29, 2026InjuryMedi-tate Ltd.2429304-2026-00076
- ITIND, WITH SNARE, STERILEMay 22, 2026InjuryMedi-tate Ltd.2429304-2026-00058
- ITIND, WITH SNARE, STERILEMar 5, 2026InjuryMedi-tate Ltd.2429304-2026-00030
- ITIND, WITH SNARE, STERILEOct 31, 2025InjuryMedi-tate Ltd.2429304-2025-00285
- ITIND, WITH SNARE, STERILESep 30, 2025InjuryMedi-tate Ltd.2429304-2025-00254
- ITIND, WITH SNARE, STERILESep 5, 2025InjuryMedi-tate Ltd.2429304-2025-00241
- ITIND, WITH SNARE, STERILEMar 25, 2025InjuryMedi-tate Ltd.2429304-2025-00106
- ITIND, WITH SNARE, STERILEMar 25, 2025InjuryMedi-tate Ltd.2429304-2025-00107
Event type breakdown
Injury16
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
510(k) clearances
4 clearances for this product code