Device |
gallbladder drainage stent and delivery system |
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. |
Physical State |
The stent has an open lumen that helps facilitate gallbladder drainage. The stent might have two flanges to help keep the bowel wall and the gallbladder in apposition. The stent might be deployed with the use of a delivery device. |
Technical Method |
The stent facilitates drainage of the gallbladder into the bowel. |
Target Area |
Gallbladder |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | QXH |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
510(k)
|
Regulation Number |
876.5016
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |