EXF — Bag, Bile Collecting Class II
FDA product code EXF covers "Bag, Bile Collecting", a Class II medical device regulated under 21 CFR 876.5010. Submissions are reviewed by the Gastroenterology, Urology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EXF
- Device Class
- Class II
- Regulation Number
- 876.5010
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003078 | merit medical systems | MERIT DRAINAGE DEPOT | December 11, 2000 |
| K990428 | remington medical | DRAINAGE BAG | August 12, 1999 |
| K980005 | medical device technologies | MANAN D BAG | January 30, 1998 |
| K961986 | manan medical products | MANAN D BAG | March 13, 1997 |
| K963849 | manan medical products | MANAN D BAG | December 13, 1996 |
| K943663 | navarre biomedical | NAVARRE 600 ML DRAINAGE BAG | September 8, 1994 |
| K911129 | medical technologies of georgia | MMG BILE BAG | August 7, 1991 |
| K903449 | uresil | URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET | September 12, 1990 |
| K901844 | uresil | URESIL TRU-CLOSE DRAINAGE BAG | June 1, 1990 |