510(k) DEN230019
DEN230019 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)". The FDA issued a decision of De Novo Granted on August 18, 2023. The device falls under product code QXH (Gallbladder Drainage Stent And Delivery System), a Class II device regulated under 21 CFR 876.5016. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 18, 2023
- Date Received
- March 27, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gallbladder Drainage Stent And Delivery System
- Device Class
- Class II
- Regulation Number
- 876.5016
- Review Panel
- GU
- Submission Type
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.