EXF · Bag, Bile Collecting
Gastroenterology, Urology · 21 CFR 876.5010 · Class 2
Overview
| Product Code | EXF |
|---|---|
| Device Name | Bag, Bile Collecting |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K003078 | MERIT DRAINAGE DEPOT | Merit Medical Systems, Inc. | Dec 11, 2000 | SESE |
| K990428 | DRAINAGE BAG | Remington Medical, Inc. | Aug 12, 1999 | SESE |
| K980005 | MANAN D BAG | Medical Device Technologies, Inc. | Jan 30, 1998 | SESE |
| K961986 | MANAN D BAG | Manan Medical Products, Inc. | Mar 13, 1997 | SESE |
| K963849 | MANAN D BAG | Manan Medical Products, Inc. | Dec 13, 1996 | SESE |
| K943663 | NAVARRE 600 ML DRAINAGE BAG | Navarre Biomedical , Ltd. | Sep 8, 1994 | SESE |
| K911129 | MMG BILE BAG | Medical Technologies of Georgia | Aug 7, 1991 | SESE |
| K903449 | URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET | Uresil Corp. | Sep 12, 1990 | SESE |
| K901844 | URESIL TRU-CLOSE DRAINAGE BAG | Uresil Corp. | Jun 1, 1990 | SESE |
Top Applicants
- Manan Medical Products, Inc. — 2 clearances
- Uresil Corp. — 2 clearances
- Medical Device Technologies, Inc. — 1 clearance
- Medical Technologies of Georgia — 1 clearance
- Merit Medical Systems, Inc. — 1 clearance
