QXHClass II
Gallbladder Drainage Stent And Delivery System
21 CFR 876.5016 / Gastroenterology, Urology
QXH is the FDA product code for Gallbladder Drainage Stent And Delivery System, a class II device type, regulated under 21 CFR 876.5016. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QXH
- Device name
- Gallbladder Drainage Stent And Delivery System
- FDA 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.
- Regulation
- 21 CFR 876.5016
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QXH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
Applicants with the most clearances
Product code QXH| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.