# LJE · Catheter, Nephrostomy

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/LJE

## Overview

- **Product Code:** LJE
- **Device Name:** Catheter, Nephrostomy
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 56)

Showing 20 most recent of 56 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250448](/device/K250448.md) | Disposable Percutaneous Nephrostomy Dilatation Kit | Shenzhen Trious Medical Technology Co., Ltd. | Jul 3, 2025 | SESE |
| [K222705](/device/K222705.md) | Introducer Needle | Youcare Technology Co.,Ltd. (Wuhan) | May 22, 2023 | SESE |
| [K211911](/device/K211911.md) | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | Coloplast Corp. | Mar 10, 2022 | SESK |
| [K201165](/device/K201165.md) | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | Coloplast Corp. | Dec 17, 2020 | SESK |
| [K191498](/device/K191498.md) | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | Cook Incorporated | Jan 29, 2020 | SESK |
| [K190903](/device/K190903.md) | Lawson Retrograde Nephrostomy Wire Puncture Set | Cook Incorporated | Dec 16, 2019 | SESE |
| [K183051](/device/K183051.md) | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | Cook Incorporated | Jul 16, 2019 | SESK |
| [K183035](/device/K183035.md) | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | Cook Incorporated | May 17, 2019 | SESK |
| [K181735](/device/K181735.md) | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | Cook Incorporated | Mar 27, 2019 | SESK |
| [K181713](/device/K181713.md) | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | Aug 17, 2018 | SESE |
| [K171601](/device/K171601.md) | Ultraxx Nephrostomy Balloon Catheter | Cook Incorporated | Feb 23, 2018 | SESE |
| [K172929](/device/K172929.md) | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath | Boston Scientific Corporation | Jan 10, 2018 | SESE |
| [K172527](/device/K172527.md) | Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe | Cook Incorporated | Oct 19, 2017 | SESE |
| [K160077](/device/K160077.md) | RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set | Jbw7 Innovations, LLC | Jul 12, 2016 | SESE |
| [K132383](/device/K132383.md) | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER | Gyrus Acmi, Inc. | Feb 4, 2014 | SESE |
| [K121614](/device/K121614.md) | NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER | Boston Scientific Corp | Sep 18, 2012 | SESE |
| [K080944](/device/K080944.md) | X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER | C.R. Bard, Inc. | Oct 23, 2008 | SESE |
| [K063632](/device/K063632.md) | X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER | C.R. Bard, Inc. | Jan 5, 2007 | SESE |
| [K051316](/device/K051316.md) | X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER | C.R. Bard, Inc. | Jul 18, 2005 | SESE |
| [K024050](/device/K024050.md) | COOK NEPHROSTOMY DILATION BALLOON CATHETER SET | Cook Urological, Inc. | Feb 27, 2003 | SESE |

## Top Applicants

- Cook Incorporated — 8 clearances
- Uresil Corp. — 5 clearances
- Cook Urological, Inc. — 4 clearances
- American Edwards Laboratories — 3 clearances
- C.R. Bard, Inc. — 3 clearances

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**Source:** [https://fda.innolitics.com/productcode/LJE](https://fda.innolitics.com/productcode/LJE)

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