Uresil Tru-Close Drainage Bag
FDA 510(k) K901844 · Uresil Corp.
510(k) numberK901844
Submission
- Device name
- Uresil Tru-Close Drainage Bag
- Applicant
- Uresil Corp.
Skokie, IL, US - Received
- April 24, 1990
- Decision date
- June 1, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K093653 | Uresil Gastrostomy Catheter Kit , Model GCL-630HBKKNT · Traditional | 02/23/2010SESK |
| K053245 | GP General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy Catheter…FGE · Special | 12/20/2005SE |
| K041995 | Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter…GBO · Special | 08/19/2004SE |
| K003753 | GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, GP…FGE · Special | 01/04/2001SE |
| K980278 | Uresil Vascu-Flo Infusion CatheterDQY · Traditional | 11/20/1998SE |
| K981344 | Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingLJE · Traditional | 09/10/1998SE |
| K980282 | Uresil Dilator with Radiopaque MarkerDRE · Traditional | 04/24/1998SE |
| K980889 | Uresil Nephro-Ureteral StentLJE · Traditional | 04/08/1998SE |
| K972582 | Uresil GuidewireFGE · Traditional | 11/21/1997SE |
| K972583 | Uresil General Purpose Drainage Catheter, Uresil Nephrostomy Catheter, Uresil Biliary…FGE · Traditional | 08/29/1997SE |
Questions and answers
When was Uresil Tru-Close Drainage Bag cleared by the FDA?
Uresil Tru-Close Drainage Bag (K901844) received a 510(k) decision of Substantially Equivalent on June 1, 1990, 38 days after the submission was received.
What is the product code of K901844?
The FDA product code is EXF – Bag, Bile Collecting, a Class II (moderate risk) device regulated under 21 CFR 876.5010.