FDA Product Code
FDA Product Code QKA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5510
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261342 | Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. | 2026-06-22 | Traditional | PDF ↗ |
| K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025) | Prodeon Medical, Inc. | 2026-03-12 | Traditional | PDF ↗ |
| K210138 | iTind System | Medi-Tate , Ltd. | 2021-06-25 | Traditional | PDF ↗ |
| DEN190020 | iTind System | Medi-Tate , Ltd. | 2020-02-25 | Direct | — |
Product code QKA · Class II · Gastroenterology, Urology. Data: openFDA.