| 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 |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.1500
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
