Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
FDA 510(k) K191498 · Cook Incorporated
510(k) numberK191498
Submission
- Device name
- Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- June 5, 2019
- Decision date
- January 29, 2020
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K171601 | Ultraxx Nephrostomy Balloon CatheterLJE · Traditional | Cook Incorporated | 02/23/2018SE |
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| K233177 | Nest VT Vitrification DeviceMQK · Traditional | 03/08/2024SE |
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| K210734 | Endovascular Dilator and SetsDRE · Special | 04/06/2021SE |
| K203670 | Extra Large Check-Flo IntroducerDYB · Traditional | 02/16/2021SE |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
| K191163 | Lumax Guiding CatheterDQY · Traditional | 12/12/2019SE |
| K190084 | McLean-Ring Enteral Feeding Tube SetKNT · Traditional | 10/11/2019SE |
| K183323 | UPJ Occlusion Balloon CatheterEYB · Traditional | 08/05/2019SESK |
Questions and answers
When was Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc cleared by the FDA?
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (K191498) received a 510(k) decision of Unknown on January 29, 2020, 238 days after the submission was received.
What is the product code of K191498?
The FDA product code is LJE – Catheter, Nephrostomy, a Unclassified device.