Gallbladder Drainage Stent And Delivery System
The gallbladder drainage stent and delivery system (product code QXH) is a Class 2 Gastroenterology/Urology prescription device (regulation 876.5016) intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder, and may include an associated delivery system. Requiring 510(k) clearance, it is classified as an implant reflecting its placement within the gastrointestinal tract. It is not life-sustaining.
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Basic Information
- Product Code
- QXH
- Device Class
- FDA class 2
- Regulation Number
- 876.5016
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230019 | AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) | Aug 18, 2023 | Unknown | Boston Scientific Corporation |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.