Atlas FDA

LJE

56 FDA 510(k) clearances · Product code

107 daysmedian time to decision
257 days90th percentile
56clearances measured

FDA profile

Official device name
Catheter, Nephrostomy
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2021: 38 · 2022: 42 · 2023: 131 · 2024: 47 · 2025: 61 · 2026: 34
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Disposable Percutaneous Nephrostomy Dilatation Kit (K250448)Shenzhen Trious Medical Technology Co., Ltd.2025-07-03
Introducer Needle (K222705)Youcare Technology Co.,Ltd. (Wuhan)2023-05-22
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets (K211911)Coloplast Corp.2022-03-10
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (K201165)Coloplast Corp.2020-12-17
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (K191498)Cook Incorporated2020-01-29
Lawson Retrograde Nephrostomy Wire Puncture Set (K190903)Cook Incorporated2019-12-16
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (K183051)Cook Incorporated2019-07-16
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle (K183035)Cook Incorporated2019-05-17
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (K181735)Cook Incorporated2019-03-27
Ultraxx Nephrostomy Balloon Catheter Set (K181713)Cook Incorporated2018-08-17
Ultraxx Nephrostomy Balloon Catheter (K171601)Cook Incorporated2018-02-23
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath (K172929)Boston Scientific Corporation2018-01-10
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 Incorporated2017-10-19
RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set (K160077)Jbw7 Innovations, LLC2016-07-12
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER (K132383)Gyrus Acmi, Inc.2014-02-04
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER (K121614)Boston Scientific Corp2012-09-18
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER (K080944)C.R. Bard, Inc.2008-10-23
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER (K063632)C.R. Bard, Inc.2007-01-05
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER (K051316)C.R. Bard, Inc.2005-07-18
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET (K024050)Cook Urological, Inc.2003-02-27
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS (K011121)Rusch Intl.2001-11-16
ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 (K990689)Zcv ,Inc.1999-09-03
URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING (K981344)Uresil Corp.1998-09-10
MANAN GENERAL UTILITY DRAINAGE CATHETER (K980193)Medical Device Technologies, Inc.1998-05-27
MANAN NEPHROSTOMY DRAINAGE CATHETER (K980192)Medical Device Technologies, Inc.1998-05-27
URESIL NEPHRO-URETERAL STENT (K980889)Uresil Corp.1998-04-08
CIRCLE NEPHROSTOMY CATHETER SET (K961933)Cook Urological, Inc.1996-07-18
MANAN GENERAL UTILITY DRAINAGE CATHETER (K953713)Manan Medical Products, Inc.1996-03-26
MANAN UNIVERSAL SUMP DRAINAGE CATHETER (K953601)Manan Medical Products, Inc.1996-03-26
MANAN NEPHROSTOMY DRAINAGE CATHETER (K953547)Manan Medical Products, Inc.1995-08-30
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (K952887)Meadox Medicals, Div. Boston Scientific Corp.1995-08-18
DILATATION CATHETER, BALLOON (K952968)Boston Scientific Corp1995-08-10
NEPHRO-URETERAL STENT (K942688)Uresil Corp.1995-06-06
PERCUTANEOUS GRAINAGE CATHETER (K943893)Menlo Care, Inc.1995-03-07
MALECOT-NEPHROSTOMY TAMPONADE CATHETER (K915209)Cook Urological, Inc.1992-11-10
URESIL NEPHROSTOMY CATHETER (K923097)Uresil Corp.1992-09-14
URESIL SUMP DRAINAGE CATHETER (K920509)Uresil Corp.1992-09-14
BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET (K891406)Cook Urological, Inc.1989-04-07
NEPHROSTOMY SET (K862742)Meadox Surgimed, Inc.1986-10-31
MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET (K850287)Mentor Corp.1985-03-07
MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET (K850286)Mentor Corp.1985-02-28
NEPHROSTOMY DRAINAGE CATHETER & STIFFENER (K845048)American Edwards Laboratories1985-01-15
NEPHROSTOMY GUIDEWIRE SHEATH (K845047)American Edwards Laboratories1985-01-15
PERCUTANEOUS NEPHROSTOMY TROCAR SYS (K844090)American Edwards Laboratories1984-12-05
CURITY SILICONE NEPHROSTOMY CATHETER (K842840)The Kendal Co.1984-10-04
E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE (K842121)E-Z-Em, Inc.1984-10-01
CURITY SUPRAPUBIC DRAINAGE SYSTEM (K842899)The Kendal Co.1984-09-10
E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS (K841720)E-Z-Em, Inc.1984-07-26
PERCUTANEOUS RETROGRADE NEPHROSTOMY (K833762)Vpi1984-02-10
NEPHROSTOMY/BILIARY DRAINAGE BAG (K834476)Vertex Medical Corp.1984-02-04
PERCUTANEOUS NEPHROSTOMY CATHETER (K833008)Medical Engineering Corp.1983-10-19
URINARY DIVERSION STENT (K830803)Van-Tec, Inc.1983-05-05
SURGITEK PERCUTANEOUS NEPHROSTOMY CATH (K830226)Medical Engineering Corp.1983-02-09
NEPHROSTOMY CATHETER (K823382)Umi, Inc.1983-01-28
HEYER-SCHUTE UNIVERSAL URETERAL STENT (K823418)American Hospital Supply Corp.1982-12-03
SURGITEK PERCUTANEOUS NEPHROST. STENT (K821776)Medical Engineering Corp.1982-08-10

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Every clearance here is in the API, with alerts when new ones post.