LJE

FDA Product Code LJE: Catheter, Nephrostomy

Leading manufacturers include Cook Incorporated, C.R. Bard, Inc. and Boston Scientific Corp.

56
Total
56
Cleared
129d
Avg days
1982
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times: 135d avg (recent)

FDA 510(k) Cleared Catheter, Nephrostomy Devices (Product Code LJE)

56 devices
1–24 of 56
Cleared Jul 03, 2025
Disposable Percutaneous Nephrostomy Dilatation Kit
K250448
Shenzhen Trious Medical Technology Co., Ltd.
Gastroenterology & Urology · 135d
Cleared May 22, 2023
Introducer Needle
K222705
Youcare Technology Co.,Ltd. (Wuhan)
General & Plastic Surgery · 257d
Cleared Mar 10, 2022
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
K211911
Coloplast Corp.
Gastroenterology & Urology · 262d
Cleared Dec 17, 2020
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
K201165
Coloplast Corp.
Gastroenterology & Urology · 230d
Cleared Jan 29, 2020
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
K191498
Cook Incorporated
Gastroenterology & Urology · 238d
Cleared Dec 16, 2019
Lawson Retrograde Nephrostomy Wire Puncture Set
K190903
Cook Incorporated
Gastroenterology & Urology · 252d
Cleared Jul 16, 2019
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
K183051
Cook Incorporated
Gastroenterology & Urology · 256d
Cleared May 17, 2019
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
K183035
Cook Incorporated
Gastroenterology & Urology · 197d
Cleared Mar 27, 2019
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
K181735
Cook Incorporated
Gastroenterology & Urology · 268d
Cleared Aug 17, 2018
Ultraxx Nephrostomy Balloon Catheter Set
K181713
Cook Incorporated
Gastroenterology & Urology · 50d
Cleared Feb 23, 2018
Ultraxx Nephrostomy Balloon Catheter
K171601
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
K172929
Boston Scientific Corporation
Gastroenterology & Urology · 107d
Cleared Oct 19, 2017
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
K172527
Cook Incorporated
Gastroenterology & Urology · 59d
Cleared Sep 18, 2012
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
K121614
Boston Scientific Corp
Gastroenterology & Urology · 109d
Cleared Oct 23, 2008
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K080944
C.R. Bard, Inc.
Gastroenterology & Urology · 203d
Cleared Jan 05, 2007
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
K063632
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 18, 2005
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K051316
C.R. Bard, Inc.
Gastroenterology & Urology · 59d
Cleared Aug 10, 1995
DILATATION CATHETER, BALLOON
K952968
Boston Scientific Corp
Gastroenterology & Urology · 44d

About Product Code LJE - Regulatory Context

510(k) Submission Activity

56 total 510(k) submissions under product code LJE since 1982, with 56 receiving FDA clearance (average review time: 129 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - LJE Product Code

FDA review times for LJE submissions have been consistent, averaging 135 days recently vs 129 days historically.

LJE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →