Drainage Bag
FDA 510(k) K990428 · Remington Medical, Inc.
510(k) numberK990428
Submission
- Device name
- Drainage Bag
- Applicant
- Remington Medical, Inc.
Alpharetta, GA, US - Received
- February 11, 1999
- Decision date
- August 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EXF – Bag, Bile Collecting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003078 | Merit Drainage DepotEXF · Traditional | Merit Medical Systems, Inc. | 12/11/2000SE |
| K980005 | Manan D BagEXF · Traditional | Medical Device Technologies, Inc. | 01/30/1998SE |
| K961986 | Manan D BagEXF · Traditional | Manan Medical Products, Inc. | 03/13/1997SE |
| K963849 | Manan D BagEXF · Traditional | Manan Medical Products, Inc. | 12/13/1996SE |
| K943663 | Navarre 600 ML Drainage BagEXF · Traditional | Navarre Biomedical , Ltd. | 09/08/1994SE |
| K911129 | MMG Bile BagEXF · Traditional | Medical Technologies of Georgia | 08/07/1991SE |
| K903449 | Uresil Tru-Close Multi-Purpose Drainage SetEXF · Traditional | Uresil Corp. | 09/12/1990SE |
| K901844 | Uresil Tru-Close Drainage BagEXF · Traditional | Uresil Corp. | 06/01/1990SE |
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Questions and answers
When was Drainage Bag cleared by the FDA?
Drainage Bag (K990428) received a 510(k) decision of Substantially Equivalent on August 12, 1999, 182 days after the submission was received.
What is the product code of K990428?
The FDA product code is EXF – Bag, Bile Collecting, a Class II (moderate risk) device regulated under 21 CFR 876.5010.