Uresil General Purpose Drainage Catheter
FDA 510(k) K912109 · Uresil Corp.
510(k) numberK912109
Submission
- Device name
- Uresil General Purpose Drainage Catheter
- Applicant
- Uresil Corp.
Skokie, IL, US - Received
- May 13, 1991
- Decision date
- August 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBO – Catheter, Nephrostomy, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041995 | Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter…GBO · Special | Uresil, LLC | 08/19/2004SE |
| K021632 | GP General Purpose Drainage Catheter; Mini-Pigtail Drainage Catheter with Locking…GBO · Special | Uresil, L.P. | 06/13/2002SE |
| K854911 | Percutaneous Nephrostomy Sets (Schuller)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854909 | Pediatric Percutaneous Nephrostomy SetsGBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854907 | Percutaneous Nephrostomy Sets (Gunther)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854906 | Percutaneous Nephrostomy Sets (Otto)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854905 | Percutaneous Nephrostomy Sets (Loop Technique)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K820867 | Percutaneous Nephrostomy SetGBO · Traditional | Van-Tec, Inc. | 04/13/1982SE |
| K781664 | Silastic Nephrostomy SystemGBO · Traditional | Dow Corning Corp. Healthcare Industries Materials | 01/22/1979SE |
| K781526 | Silastic U-Tube KitGBO · Traditional | Dow Corning Corp. Healthcare Industries Materials | 09/20/1978SE |
More from Dow Corning Corp. Healthcare Industries Materials
| 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 General Purpose Drainage Catheter cleared by the FDA?
Uresil General Purpose Drainage Catheter (K912109) received a 510(k) decision of Substantially Equivalent on August 12, 1991, 91 days after the submission was received.
What is the product code of K912109?
The FDA product code is GBO – Catheter, Nephrostomy, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4200.