QXH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gallbladder Drainage Stent And Delivery System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5016
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant
- FDA definition
- A gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system.
- Adverse events (MAUDE)
- 2025: 45 · 2026: 63
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) (DEN230019) | Boston Scientific Corporation | 2023-08-18 |
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