QKA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5510
- Medical specialty
- Gastroenterology, Urology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Urocross Expander System (UES-2018-C1) (K261342) | Prodeon Medical, Inc. | 2026-06-22 |
| Urocross Expander System (Model Numbers ES2018 and ES3025) (K253525) | Prodeon Medical, Inc. | 2026-03-12 |
| iTind System (K210138) | Medi-Tate , Ltd. | 2021-06-25 |
| iTind System (DEN190020) | Medi-Tate , Ltd. | 2020-02-25 |
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