DEN230019 is an FDA 510(k) submission for the AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent). This device is classified as a Gallbladder Drainage Stent And Delivery System (Class II - Special Controls, product code QXH).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Not Cleared (DENG) decision on August 18, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5016. 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..
| 510(k) Number | DEN230019 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 27, 2023 |
| Decision Date | August 18, 2023 |
| Days to Decision | 144 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | QXH — Gallbladder Drainage Stent And Delivery System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5016 |
| 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. |