Navarre 600 ML Drainage Bag
FDA 510(k) K943663 · Navarre Biomedical , Ltd.
510(k) numberK943663
Submission
- Device name
- Navarre 600 ML Drainage Bag
- Applicant
- Navarre Biomedical , Ltd.
Plymouth, MN, US - Received
- July 28, 1994
- Decision date
- September 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K990428 | Drainage BagEXF · Traditional | Remington Medical, Inc. | 08/12/1999SE |
| 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 |
| 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 |
More from Uresil Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K955110 | Navarre Percutaneous Biliary DrainageFGE · Traditional | 11/07/1996SE |
| K955505 | Opti-Drain Multi-Use Drainage CatheterGBX · Traditional | 02/07/1996SE |
| K945909 | Navarre N-Fuser(Tm) Peripheral Infusion CatheterKRA · Traditional | 06/02/1995SE |
| K951907 | Navarre Locking Pigtail Universal Drainage CatheterGBX · Traditional | 05/15/1995SE |
| K951475 | Navarre Universal Drainage CatheterGBX · Traditional | 04/24/1995SE |
| K942315 | Navarre Percutaneous Access SetKGZ · Traditional | 07/08/1994SE |
| K933600 | Navarre Biomedical Tip-Locking Drainage CathetersGBX · Traditional | 03/28/1994SE |
| K932391 | Navarre Biomedical Universal Drainage Catheter SetGBX · Traditional | 01/27/1994SE |
Questions and answers
When was Navarre 600 ML Drainage Bag cleared by the FDA?
Navarre 600 ML Drainage Bag (K943663) received a 510(k) decision of Substantially Equivalent on September 8, 1994, 42 days after the submission was received.
What is the product code of K943663?
The FDA product code is EXF – Bag, Bile Collecting, a Class II (moderate risk) device regulated under 21 CFR 876.5010.