Product code QXH— Gastroenterology, Urology
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent) +1 more
- Classification name
- Gallbladder Drainage Stent And Delivery System
- Device class
- Class 2
- Regulation
- 21 CFR 876.5016
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QXH
FDA has cleared device under product code QXH, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QXH
Adverse events under product code QXH
product code QXH- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code QXH
Data sourced from openFDA. This site is unofficial and independent of the FDA.