Product code EXF
- Device name
- Bag, Bile Collecting
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5010
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003078 | MERIT DRAINAGE DEPOT | Merit Medical Systems, Inc. | 2000-12-11 |
| K990428 | DRAINAGE BAG | Remington Medical, Inc. | 1999-08-12 |
| K980005 | MANAN D BAG | Medical Device Technologies, Inc. | 1998-01-30 |
| K961986 | MANAN D BAG | Manan Medical Products, Inc. | 1997-03-13 |
| K963849 | MANAN D BAG | Manan Medical Products, Inc. | 1996-12-13 |
| K943663 | NAVARRE 600 ML DRAINAGE BAG | Navarre Biomedical , Ltd. | 1994-09-08 |
| K911129 | MMG BILE BAG | Medical Technologies of Georgia | 1991-08-07 |
| K903449 | URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET | Uresil Corp. | 1990-09-12 |
| K901844 | URESIL TRU-CLOSE DRAINAGE BAG | Uresil Corp. | 1990-06-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00661613318038 | Biliary Drainage Kit | Marlen Manufacturing And Development Co. | 2026-05-03 |
| 10884450859770 | Merit Drainage Depot™ | Merit Medical Systems, Inc. | 2025-05-29 |
| 00884450859773 | Merit Drainage Depot™ | Merit Medical Systems, Inc. | 2025-05-29 |
| 20817640020473 | Drainage Bag | URESIL, LLC | 2022-06-03 |
| 00817640020479 | Drainage Bag | URESIL, LLC | 2022-06-03 |
| 10817640020568 | Gravity Drainage Bag | URESIL, LLC | 2021-11-04 |
| 10817640020551 | Gravity Drainage Bag | URESIL, LLC | 2021-11-04 |
| 00817640020554 | Optimus Gravity Drainage Bag | URESIL, LLC | 2021-11-04 |
| 00817640020561 | Optimus Gravity Drainage Bag | URESIL, LLC | 2021-11-04 |
| H862TC6000 | Gravity Drainage Bag | URESIL, LLC | 2017-09-11 |
| H862TC6002 | Gravity Drainage Bag | URESIL, LLC | 2017-09-11 |
| H862PDC362 | Gravity Drainage Bag | URESIL, LLC | 2017-09-11 |
| H862TC600L0 | Gravity Drainage Bag | URESIL, LLC | 2017-09-11 |
| H862TC600L2 | Gravity Drainage Bag | URESIL, LLC | 2017-09-11 |
| H862PDC360 | Drainage Bag | URESIL, LLC | 2017-09-11 |
| 00884450025604 | Merit Drainage Depot™ | Merit Medical Systems, Inc. | 2016-11-03 |
| 10884450025601 | Merit Drainage Depot™ | Merit Medical Systems, Inc. | 2016-11-03 |
| 00884450232231 | Merit Drainage Depot™ | Merit Medical Systems, Inc. | 2016-09-24 |
| 10884450008253 | Merit Drainage Depot™ | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450008256 | Merit Drainage Depot™ | Merit Medical Systems, Inc. | 2016-09-24 |
| 10884450232238 | Merit Drainage Depot™ | Merit Medical Systems, Inc. | 2016-09-24 |
| 00813079020004 | Drainage Bag | REMINGTON MEDICAL, INC. | 2016-09-21 |
| 20886333001426 | Drainage Bag | ARGON MEDICAL DEVICES, INC. | 2016-09-09 |
| 20886333001433 | Drainage Bag | ARGON MEDICAL DEVICES, INC. | 2016-09-09 |
| 00886333001439 | Drainage Bag | ARGON MEDICAL DEVICES, INC. | 2016-09-09 |
| 00886333001422 | Drainage Bag | ARGON MEDICAL DEVICES, INC. | 2016-09-09 |
| 00801741036873 | VacuBag | Bard Access Systems, Inc. | 2015-12-04 |
| 00801741036880 | Navarre | Bard Access Systems, Inc. | 2015-11-20 |
| 00801741011627 | Davol Bile Bag, Small | C. R. Bard, Inc. | 2015-05-29 |
| 00801741011610 | Davol Bile Bag, Regular | C. R. Bard, Inc. | 2015-05-29 |