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U.S. Department of Health and Human Services

Product Classification
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Device endoscopic retrograde cholangiopancreatography (ercp) cannula
Regulation Description Endoscope and accessories.
Definition To identify stones, tumors, or narrowing in the biliary tree.
Physical State catheter. may include radiopaque markings
Technical Method Passed through an endoscope (duodenoscope) into the biliary duct to inject x-ray contract media into the biliary tree.
Target Area biliary tree
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeODD
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 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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