R STENT BILIARY ENDOPROSTHESIS
Device Facts
| Record ID | K010107 |
|---|---|
| Device Name | R STENT BILIARY ENDOPROSTHESIS |
| Applicant | Orbus Medical Technologies |
| Product Code | FGE · Gastroenterology, Urology |
| Decision Date | Jul 31, 2001 |
| Decision | SESU |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
Special Controls
*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
