LJE

Death

6

Total

6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit Shenzhen Trious Medical Technology Co., Ltd. · 2025-07-03
• K222705 — Introducer Needle Youcare Technology Co.,Ltd. (Wuhan) · 2023-05-22
• K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets Coloplast Corp. · 2022-03-10
• K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath Coloplast Corp. · 2020-12-17
• K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc Cook Incorporated · 2020-01-29
• K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set Cook Incorporated · 2019-12-16
• K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Cook Incorporated · 2019-07-16
• K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle Cook Incorporated · 2019-05-17
• K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set Cook Incorporated · 2019-03-27
• K181713 — Ultraxx Nephrostomy Balloon Catheter Set Cook Incorporated · 2018-08-17
• K171601 — Ultraxx Nephrostomy Balloon Catheter Cook Incorporated · 2018-02-23
• K172929 — Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath Boston Scientific Corporation · 2018-01-10
• 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 Cook Incorporated · 2017-10-19
• K160077 — RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set Jbw7 Innovations, LLC · 2016-07-12
• K132383 — GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER Gyrus Acmi, Inc. · 2014-02-04
• K121614 — NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER Boston Scientific Corp · 2012-09-18
• K080944 — X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER C.R. Bard, Inc. · 2008-10-23
• K063632 — X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER C.R. Bard, Inc. · 2007-01-05
• K051316 — X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER C.R. Bard, Inc. · 2005-07-18
• K024050 — COOK NEPHROSTOMY DILATION BALLOON CATHETER SET Cook Urological, Inc. · 2003-02-27
• K011121 — RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS Rusch Intl. · 2001-11-16
• K990689 — ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 Zcv ,Inc. · 1999-09-03
• K981344 — URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING Uresil Corp. · 1998-09-10
• K980192 — MANAN NEPHROSTOMY DRAINAGE CATHETER Medical Device Technologies, Inc. · 1998-05-27
• K980193 — MANAN GENERAL UTILITY DRAINAGE CATHETER Medical Device Technologies, Inc. · 1998-05-27
• K980889 — URESIL NEPHRO-URETERAL STENT Uresil Corp. · 1998-04-08
• K961933 — CIRCLE NEPHROSTOMY CATHETER SET Cook Urological, Inc. · 1996-07-18
• K953601 — MANAN UNIVERSAL SUMP DRAINAGE CATHETER Manan Medical Products, Inc. · 1996-03-26
• K953713 — MANAN GENERAL UTILITY DRAINAGE CATHETER Manan Medical Products, Inc. · 1996-03-26
• K953547 — MANAN NEPHROSTOMY DRAINAGE CATHETER Manan Medical Products, Inc. · 1995-08-30
• K952887 — NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. · 1995-08-18
• K952968 — DILATATION CATHETER, BALLOON Boston Scientific Corp · 1995-08-10
• K942688 — NEPHRO-URETERAL STENT Uresil Corp. · 1995-06-06
• K943893 — PERCUTANEOUS GRAINAGE CATHETER Menlo Care, Inc. · 1995-03-07
• K915209 — MALECOT-NEPHROSTOMY TAMPONADE CATHETER Cook Urological, Inc. · 1992-11-10
• K920509 — URESIL SUMP DRAINAGE CATHETER Uresil Corp. · 1992-09-14
• K923097 — URESIL NEPHROSTOMY CATHETER Uresil Corp. · 1992-09-14
• K891406 — BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET Cook Urological, Inc. · 1989-04-07
• K862742 — NEPHROSTOMY SET Meadox Surgimed, Inc. · 1986-10-31
• K850287 — MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET Mentor Corp. · 1985-03-07
• K850286 — MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET Mentor Corp. · 1985-02-28
• K845047 — NEPHROSTOMY GUIDEWIRE SHEATH American Edwards Laboratories · 1985-01-15
• K845048 — NEPHROSTOMY DRAINAGE CATHETER & STIFFENER American Edwards Laboratories · 1985-01-15
• K844090 — PERCUTANEOUS NEPHROSTOMY TROCAR SYS American Edwards Laboratories · 1984-12-05
• K842840 — CURITY SILICONE NEPHROSTOMY CATHETER The Kendal Co. · 1984-10-04
• K842121 — E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE E-Z-Em, Inc. · 1984-10-01
• K842899 — CURITY SUPRAPUBIC DRAINAGE SYSTEM The Kendal Co. · 1984-09-10
• K841720 — E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS E-Z-Em, Inc. · 1984-07-26
• K833762 — PERCUTANEOUS RETROGRADE NEPHROSTOMY Vpi · 1984-02-10
• K834476 — NEPHROSTOMY/BILIARY DRAINAGE BAG Vertex Medical Corp. · 1984-02-04
• K833008 — PERCUTANEOUS NEPHROSTOMY CATHETER Medical Engineering Corp. · 1983-10-19
• K830803 — URINARY DIVERSION STENT Van-Tec, Inc. · 1983-05-05
• K830226 — SURGITEK PERCUTANEOUS NEPHROSTOMY CATH Medical Engineering Corp. · 1983-02-09
• K823382 — NEPHROSTOMY CATHETER Umi, Inc. · 1983-01-28
• K823418 — HEYER-SCHUTE UNIVERSAL URETERAL STENT American Hospital Supply Corp. · 1982-12-03
• K821776 — SURGITEK PERCUTANEOUS NEPHROST. STENT Medical Engineering Corp. · 1982-08-10