FDA Product Code
FDA Product Code EXF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5010
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K003078 | MERIT DRAINAGE DEPOT | Merit Medical Systems, Inc. | 2000-12-11 | Traditional | PDF ↗ |
| K990428 | DRAINAGE BAG | Remington Medical, Inc. | 1999-08-12 | Traditional | PDF ↗ |
| K980005 | MANAN D BAG | Medical Device Technologies, Inc. | 1998-01-30 | Traditional | PDF ↗ |
| K961986 | MANAN D BAG | Manan Medical Products, Inc. | 1997-03-13 | Traditional | PDF ↗ |
| K963849 | MANAN D BAG | Manan Medical Products, Inc. | 1996-12-13 | Traditional | PDF ↗ |
| K943663 | NAVARRE 600 ML DRAINAGE BAG | Navarre Biomedical , Ltd. | 1994-09-08 | Traditional | PDF ↗ |
| K911129 | MMG BILE BAG | Medical Technologies of Georgia | 1991-08-07 | Traditional | PDF ↗ |
| K903449 | URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET | Uresil Corp. | 1990-09-12 | Traditional | PDF ↗ |
| K901844 | URESIL TRU-CLOSE DRAINAGE BAG | Uresil Corp. | 1990-06-01 | Traditional | PDF ↗ |
Product code EXF · Class II · Gastroenterology, Urology. Data: openFDA.