FDA Product Code
FDA Product Code QXH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5016
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN230019 | AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) | Boston Scientific Corporation | 2023-08-18 | Direct | — |
Product code QXH · Class II · Gastroenterology, Urology. Data: openFDA.