Bag, Bile Collecting
The bile collecting bag is a drainage collection device attached to biliary drainage catheters or tubes to collect bile externally from the biliary system in patients with biliary obstruction or following hepatobiliary surgery. It is classified as FDA Class 2, representing moderate risk, and requires special controls. The product code is EXF, regulated under 21 CFR 876.5010 in the Gastroenterology, Urology specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
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Basic Information
- Product Code
- EXF
- Device Class
- FDA class 2
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K003078 | MERIT DRAINAGE DEPOT | Dec 11, 2000 | Substantially Equivalent | Merit Medical Systems, Inc. |
| K990428 | DRAINAGE BAG | Aug 12, 1999 | Substantially Equivalent | Remington Medical, Inc. |
| K980005 | MANAN D BAG | Jan 30, 1998 | Substantially Equivalent | Medical Device Technologies, Inc. |
| K961986 | MANAN D BAG | Mar 13, 1997 | Substantially Equivalent | Manan Medical Products, Inc. |
| K963849 | MANAN D BAG | Dec 13, 1996 | Substantially Equivalent | Manan Medical Products, Inc. |
| K943663 | NAVARRE 600 ML DRAINAGE BAG | Sep 08, 1994 | Substantially Equivalent | Navarre Biomedical , Ltd. |
| K911129 | MMG BILE BAG | Aug 07, 1991 | Substantially Equivalent | Medical Technologies of Georgia |
| K903449 | URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET | Sep 12, 1990 | Substantially Equivalent | Uresil Corp. |
| K901844 | URESIL TRU-CLOSE DRAINAGE BAG | Jun 01, 1990 | Substantially Equivalent | Uresil Corp. |
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.