Malecot-Nephrostomy Tamponade Catheter
FDA 510(k) K915209 · Cook Urological, Inc.
510(k) numberK915209
Submission
- Device name
- Malecot-Nephrostomy Tamponade Catheter
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- November 18, 1991
- Decision date
- November 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LJE – Catheter, Nephrostomy
- Device class
- Unclassified
Other 510(k)s with product code LJE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250448 | Disposable Percutaneous Nephrostomy Dilatation KitLJE · Traditional | Shenzhen Trious Medical Technology Co., Ltd. | 07/03/2025SE |
| K222705 | Introducer NeedleLJE · Traditional | Youcare Technology Co.,Ltd. (Wuhan) | 05/22/2023SE |
| K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits…LJE · Traditional | Coloplast Corp. | 03/10/2022SESK |
| K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathLJE · Traditional | Coloplast Corp. | 12/17/2020SESK |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional | Cook Incorporated | 01/29/2020SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | Cook Incorporated | 12/16/2019SE |
| K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetLJE · Traditional | Cook Incorporated | 07/16/2019SESK |
| K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar NeedleLJE · Traditional | Cook Incorporated | 05/17/2019SESK |
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetLJE · Traditional | Cook Incorporated | 03/27/2019SESK |
| K181713 | Ultraxx Nephrostomy Balloon Catheter SetLJE · Traditional | Cook Incorporated | 08/17/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)KNA · Traditional | 05/06/2011SE |
| K091767 | 3 Way Silicone Foley Balloon CatheterEZL · Traditional | 10/09/2009SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 11/07/2008SE |
| K082536 | Cook Wire GuidesOCY · Traditional | 10/27/2008SE |
| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | 09/25/2008SE |
| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | 11/20/2007SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | 08/17/2006SE |
Questions and answers
When was Malecot-Nephrostomy Tamponade Catheter cleared by the FDA?
Malecot-Nephrostomy Tamponade Catheter (K915209) received a 510(k) decision of Substantially Equivalent on November 10, 1992, 358 days after the submission was received.
What is the product code of K915209?
The FDA product code is LJE – Catheter, Nephrostomy, a Unclassified device.