Manan D Bag
FDA 510(k) K963849 · Manan Medical Products, Inc.
510(k) numberK963849
Submission
- Device name
- Manan D Bag
- Applicant
- Manan Medical Products, Inc.
Northbrook, IL, US - Received
- September 25, 1996
- Decision date
- December 13, 1996
- 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 |
| 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 |
| 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 |
More from Uresil Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K052802 | Manan Bio-Cut Soft Tissue Biopsy NeedleKNW · Special | 11/01/2005SE |
| K011209 | Manan Spritacre Spinal NeedlesBSP · Traditional | 06/26/2001SE |
| K983620 | Manan Spinal NeedlesBSP · Traditional | 01/08/1999SE |
| K980536 | Epidural NeedleBSP · Traditional | 07/31/1998SE |
| K981386 | Manan Blunt NeedleFPA · Traditional | 06/29/1998SE |
| K980211 | MRI Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesKNW · Traditional | 02/06/1998SE |
| K974446 | Manan Automatic Cutting NeedleKNW · Traditional | 01/08/1998SE |
| K962977 | MRI Compatible Biopsy NeedlesKNW · Traditional | 10/09/1997SE |
| K963767 | Manan V.S. Access Needle/SetFGE · Traditional | 05/16/1997SE |
| K961986 | Manan D BagEXF · Traditional | 03/13/1997SE |
Questions and answers
When was Manan D Bag cleared by the FDA?
Manan D Bag (K963849) received a 510(k) decision of Substantially Equivalent on December 13, 1996, 79 days after the submission was received.
What is the product code of K963849?
The FDA product code is EXF – Bag, Bile Collecting, a Class II (moderate risk) device regulated under 21 CFR 876.5010.