FDA Product Code
FDA Product Code QXU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5710
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243233 | esolution® Esophageal Retractor | S4 Medical Corp. | 2024-11-09 | Special | PDF ↗ |
| DEN230006 | esolution | S4 Medical Corp. | 2023-09-06 | Direct | — |
Product code QXU · Class II · Cardiovascular. Data: openFDA.