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U.S. Department of Health and Human Services

Product Classification
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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 CodeQXH
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
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
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