Panels › Gastroenterology, Urology › Product code QKA · Class 2
Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Regulation 876.5510
2510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QKA
| Company | 510(k)s | Recalls |
|---|---|---|
| Medi-Tate , Ltd. | 2 | 0 |
| Prodeon Medical, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 2026 | K261342 | Urocross Expander System (UES-2018-C1) Prodeon Medical, Inc. | QKA |
| Mar 12, 2026 | K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025) Prodeon Medical, Inc. | QKA |
| Jun 25, 2021 | K210138 | iTind System Medi-Tate , Ltd., IL | QKA |
| Feb 25, 2020 | DEN190020 | iTind System Medi-Tate , Ltd., IL | QKA |
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