FDA Product Code
FDA Product Code QXM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5305
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253651 | Revi System | Bluewind Medical , Ltd. | 2026-07-28 | Traditional | PDF ↗ |
| K252391 | Revi System | Bluewind Medical , Ltd. | 2025-12-12 | Traditional | PDF ↗ |
| K240037 | Revi System | Bluewind Medical , Ltd. | 2024-05-02 | Traditional | PDF ↗ |
| DEN220073 | Revi System | Bluewind Medical , Ltd. | 2023-08-16 | Direct | — |
Product code QXM · Class II · Gastroenterology, Urology. Data: openFDA.