Product Code: LJE FDA unclassified

Catheter, Nephrostomy

Unknown

A nephrostomy catheter is a tube inserted percutaneously through the skin and into the renal pelvis to provide drainage of the kidney when normal urine flow through the ureter is obstructed due to stones, strictures, tumors, or post-surgical complications. This device is currently unclassified by the FDA, meaning a formal regulatory risk classification has not yet been established. It carries product code LJE and no regulation number or medical specialty has been assigned. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LJE
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250448	Disposable Percutaneous Nephrostomy Dilatation Kit	Jul 03, 2025	Substantially Equivalent	Shenzhen Trious Medical Technology Co., Ltd.
K222705	Introducer Needle	May 22, 2023	Substantially Equivalent	Youcare Technology Co.,Ltd. (Wuhan)
K211911	Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets	Mar 10, 2022	Unknown	Coloplast Corp.
K201165	In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath	Dec 17, 2020	Unknown	Coloplast Corp.
K191498	Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc	Jan 29, 2020	Unknown	Cook Incorporated
K190903	Lawson Retrograde Nephrostomy Wire Puncture Set	Dec 16, 2019	Substantially Equivalent	Cook Incorporated
K183051	Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set	Jul 16, 2019	Unknown	Cook Incorporated
K183035	Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle	May 17, 2019	Unknown	Cook Incorporated
K181735	Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set	Mar 27, 2019	Unknown	Cook Incorporated
K181713	Ultraxx Nephrostomy Balloon Catheter Set	Aug 17, 2018	Substantially Equivalent	Cook Incorporated
K171601	Ultraxx Nephrostomy Balloon Catheter	Feb 23, 2018	Substantially Equivalent	Cook Incorporated
K172929	Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath	Jan 10, 2018	Substantially Equivalent	Boston Scientific Corporation
K172527	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	Oct 19, 2017	Substantially Equivalent	Cook Incorporated
K160077	RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set	Jul 12, 2016	Substantially Equivalent	Jbw7 Innovations, LLC
K132383	GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER	Feb 04, 2014	Substantially Equivalent	Gyrus Acmi, Inc.
K121614	NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER	Sep 18, 2012	Substantially Equivalent	Boston Scientific Corp
K080944	X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER	Oct 23, 2008	Substantially Equivalent	C.R. Bard, Inc.
K063632	X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER	Jan 05, 2007	Substantially Equivalent	C.R. Bard, Inc.
K051316	X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER	Jul 18, 2005	Substantially Equivalent	C.R. Bard, Inc.
K024050	COOK NEPHROSTOMY DILATION BALLOON CATHETER SET	Feb 27, 2003	Substantially Equivalent	Cook Urological, Inc.
K011121	RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS	Nov 16, 2001	Substantially Equivalent	Rusch Intl.
K990689	ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9	Sep 03, 1999	Substantially Equivalent	Zcv ,Inc.
K981344	URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING	Sep 10, 1998	Substantially Equivalent	Uresil Corp.
K980193	MANAN GENERAL UTILITY DRAINAGE CATHETER	May 27, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K980192	MANAN NEPHROSTOMY DRAINAGE CATHETER	May 27, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K980889	URESIL NEPHRO-URETERAL STENT	Apr 08, 1998	Substantially Equivalent	Uresil Corp.
K961933	CIRCLE NEPHROSTOMY CATHETER SET	Jul 18, 1996	Substantially Equivalent	Cook Urological, Inc.
K953713	MANAN GENERAL UTILITY DRAINAGE CATHETER	Mar 26, 1996	Substantially Equivalent	Manan Medical Products, Inc.
K953601	MANAN UNIVERSAL SUMP DRAINAGE CATHETER	Mar 26, 1996	Substantially Equivalent	Manan Medical Products, Inc.
K953547	MANAN NEPHROSTOMY DRAINAGE CATHETER	Aug 30, 1995	Substantially Equivalent	Manan Medical Products, Inc.
K952887	NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER	Aug 18, 1995	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K952968	DILATATION CATHETER, BALLOON	Aug 10, 1995	Substantially Equivalent	Boston Scientific Corp
K942688	NEPHRO-URETERAL STENT	Jun 06, 1995	Substantially Equivalent	Uresil Corp.
K943893	PERCUTANEOUS GRAINAGE CATHETER	Mar 07, 1995	Substantially Equivalent	Menlo Care, Inc.
K915209	MALECOT-NEPHROSTOMY TAMPONADE CATHETER	Nov 10, 1992	Substantially Equivalent	Cook Urological, Inc.
K923097	URESIL NEPHROSTOMY CATHETER	Sep 14, 1992	Substantially Equivalent	Uresil Corp.
K920509	URESIL SUMP DRAINAGE CATHETER	Sep 14, 1992	Substantially Equivalent	Uresil Corp.
K891406	BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET	Apr 07, 1989	Substantially Equivalent	Cook Urological, Inc.
K862742	NEPHROSTOMY SET	Oct 31, 1986	Substantially Equivalent	Meadox Surgimed, Inc.
K850287	MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET	Mar 07, 1985	Substantially Equivalent	Mentor Corp.
K850286	MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET	Feb 28, 1985	Substantially Equivalent	Mentor Corp.
K845048	NEPHROSTOMY DRAINAGE CATHETER & STIFFENER	Jan 15, 1985	Substantially Equivalent	American Edwards Laboratories
K845047	NEPHROSTOMY GUIDEWIRE SHEATH	Jan 15, 1985	Substantially Equivalent	American Edwards Laboratories
K844090	PERCUTANEOUS NEPHROSTOMY TROCAR SYS	Dec 05, 1984	Substantially Equivalent	American Edwards Laboratories
K842840	CURITY SILICONE NEPHROSTOMY CATHETER	Oct 04, 1984	Substantially Equivalent	The Kendal Co.
K842121	E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE	Oct 01, 1984	Substantially Equivalent	E-Z-Em, Inc.
K842899	CURITY SUPRAPUBIC DRAINAGE SYSTEM	Sep 10, 1984	Substantially Equivalent	The Kendal Co.
K841720	E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS	Jul 26, 1984	Substantially Equivalent	E-Z-Em, Inc.
K833762	PERCUTANEOUS RETROGRADE NEPHROSTOMY	Feb 10, 1984	Substantially Equivalent	Vpi
K834476	NEPHROSTOMY/BILIARY DRAINAGE BAG	Feb 04, 1984	Substantially Equivalent	Vertex Medical Corp.
K833008	PERCUTANEOUS NEPHROSTOMY CATHETER	Oct 19, 1983	Substantially Equivalent	Medical Engineering Corp.
K830803	URINARY DIVERSION STENT	May 05, 1983	Substantially Equivalent	Van-Tec, Inc.
K830226	SURGITEK PERCUTANEOUS NEPHROSTOMY CATH	Feb 09, 1983	Substantially Equivalent	Medical Engineering Corp.
K823382	NEPHROSTOMY CATHETER	Jan 28, 1983	Substantially Equivalent	Umi, Inc.
K823418	HEYER-SCHUTE UNIVERSAL URETERAL STENT	Dec 03, 1982	Substantially Equivalent	American Hospital Supply Corp.
K821776	SURGITEK PERCUTANEOUS NEPHROST. STENT	Aug 10, 1982	Substantially Equivalent	Medical Engineering Corp.