QXH — Gallbladder Drainage Stent And Delivery System Class II
FDA product code QXH covers "Gallbladder Drainage Stent And Delivery System", a Class II medical device regulated under 21 CFR 876.5016. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXH
- Device Class
- Class II
- Regulation Number
- 876.5016
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230019 | boston scientific corporation | AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AX | August 18, 2023 |