ClearanceBrief
Product code LJE ยท Class U

Catheter, Nephrostomy

0510(k)s in 12 months (56 all time)
1recalls in 12 months (12 all time)
10recalls that name a 510(k)
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Top companies in LJE

Company510(k)sRecalls
Cook Incorporated86
Boston Scientific Corp34
Uresil Corp.50
C.R. Bard, Inc.31
Cook Urological, Inc.40
American Edwards Laboratories30
Manan Medical Products, Inc.30
Medical Engineering Corp.30
Coloplast Corp.20
E-Z-Em, Inc.20
Decided510(k)Device and applicantCode
Jul 3, 2025K250448Disposable Percutaneous Nephrostomy Dilatation Kit
Shenzhen Trious Medical Technology Co., Ltd., CN
LJE
May 22, 2023K222705Introducer Needle
Youcare Technology Co.,Ltd. (Wuhan), CN
LJE
Mar 10, 2022K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
Coloplast Corp.
LJE
Dec 17, 2020K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
Coloplast Corp.
LJE
Jan 29, 2020K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
Cook Incorporated
LJE
Dec 16, 2019K190903Lawson Retrograde Nephrostomy Wire Puncture Set
Cook Incorporated
LJE
Jul 16, 2019K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
Cook Incorporated
LJE
May 17, 2019K183035Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
Cook Incorporated
LJE
Mar 27, 2019K181735Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
Cook Incorporated
LJE
Aug 17, 2018K181713Ultraxx Nephrostomy Balloon Catheter Set
Cook Incorporated
LJE
Feb 23, 2018K171601Ultraxx Nephrostomy Balloon Catheter
Cook Incorporated
LJE
Jan 10, 2018K172929Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
Boston Scientific Corporation
LJE
Oct 19, 2017K172527Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, A
Cook Incorporated
LJE
Jul 12, 2016K160077RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
Jbw7 Innovations, LLC
LJE
Feb 4, 2014K132383GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
Gyrus Acmi, Inc.
LJE
Sep 18, 2012K121614NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
Boston Scientific Corp
LJE
Oct 23, 2008K080944X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
C.R. Bard, Inc.
LJE
Jan 5, 2007K063632X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
C.R. Bard, Inc.
LJE
Jul 18, 2005K051316X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
C.R. Bard, Inc.
LJE
Feb 27, 2003K024050COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
Cook Urological, Inc.
LJE
Nov 16, 2001K011121RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
Rusch Intl.
LJE
Sep 3, 1999K990689ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
Zcv ,Inc.
LJE
Sep 10, 1998K981344URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
Uresil Corp.
LJE
May 27, 1998K980193MANAN GENERAL UTILITY DRAINAGE CATHETER
Medical Device Technologies, Inc.
LJE
May 27, 1998K980192MANAN NEPHROSTOMY DRAINAGE CATHETER
Medical Device Technologies, Inc.
LJE
Apr 8, 1998K980889URESIL NEPHRO-URETERAL STENT
Uresil Corp.
LJE
Jul 18, 1996K961933CIRCLE NEPHROSTOMY CATHETER SET
Cook Urological, Inc.
LJE
Mar 26, 1996K953713MANAN GENERAL UTILITY DRAINAGE CATHETER
Manan Medical Products, Inc.
LJE
Mar 26, 1996K953601MANAN UNIVERSAL SUMP DRAINAGE CATHETER
Manan Medical Products, Inc.
LJE
Aug 30, 1995K953547MANAN NEPHROSTOMY DRAINAGE CATHETER
Manan Medical Products, Inc.
LJE
Aug 18, 1995K952887NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
Meadox Medicals, Div. Boston Scientific Corp.
LJE
Aug 10, 1995K952968DILATATION CATHETER, BALLOON
Boston Scientific Corp
LJE
Jun 6, 1995K942688NEPHRO-URETERAL STENT
Uresil Corp.
LJE
Mar 7, 1995K943893PERCUTANEOUS GRAINAGE CATHETER
Menlo Care, Inc.
LJE
Nov 10, 1992K915209MALECOT-NEPHROSTOMY TAMPONADE CATHETER
Cook Urological, Inc.
LJE
Sep 14, 1992K923097URESIL NEPHROSTOMY CATHETER
Uresil Corp.
LJE
Sep 14, 1992K920509URESIL SUMP DRAINAGE CATHETER
Uresil Corp.
LJE
Apr 7, 1989K891406BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET
Cook Urological, Inc.
LJE
Oct 31, 1986K862742NEPHROSTOMY SET
Meadox Surgimed, Inc.
LJE
Mar 7, 1985K850287MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET
Mentor Corp.
LJE
Feb 28, 1985K850286MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET
Mentor Corp.
LJE
Jan 15, 1985K845048NEPHROSTOMY DRAINAGE CATHETER & STIFFENER
American Edwards Laboratories
LJE
Jan 15, 1985K845047NEPHROSTOMY GUIDEWIRE SHEATH
American Edwards Laboratories
LJE
Dec 5, 1984K844090PERCUTANEOUS NEPHROSTOMY TROCAR SYS
American Edwards Laboratories
LJE
Oct 4, 1984K842840CURITY SILICONE NEPHROSTOMY CATHETER
The Kendal Co.
LJE
Oct 1, 1984K842121E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE
E-Z-Em, Inc.
LJE
Sep 10, 1984K842899CURITY SUPRAPUBIC DRAINAGE SYSTEM
The Kendal Co.
LJE
Jul 26, 1984K841720E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS
E-Z-Em, Inc.
LJE
Feb 10, 1984K833762PERCUTANEOUS RETROGRADE NEPHROSTOMY
Vpi
LJE
Feb 4, 1984K834476NEPHROSTOMY/BILIARY DRAINAGE BAG
Vertex Medical Corp.
LJE

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