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 Code | ODD |
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 |
|
|