QKA — Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia Class II
FDA product code QKA covers "Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia", a Class II medical device regulated under 21 CFR 876.5510. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261342 | prodeon medical | Urocross Expander System (UES-2018-C1) | June 22, 2026 |
| 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 |