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Catheter, Nephrostomy

FDA product code LJE · 55 cleared devices

Class U Unknown

Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1982-08-10 – 2025-07-03

LJE 2025-07-03

Disposable Percutaneous Nephrostomy Dilatation Kit

Applicant Shenzhen Trious Medical Technology Co., Ltd.

K number K250448

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LJE 2023-05-22

Introducer Needle

Applicant Youcare Technology Co.,Ltd. (Wuhan)

K number K222705

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LJE 2022-03-10

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets

Applicant Coloplast Corp.

K number K211911

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LJE 2020-12-17

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

Applicant Coloplast Corp.

K number K201165

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LJE 2020-01-29

Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc

Applicant Cook Incorporated

K number K191498

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LJE 2019-12-16

Lawson Retrograde Nephrostomy Wire Puncture Set

Applicant Cook Incorporated

K number K190903

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LJE 2019-07-16

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set

Applicant Cook Incorporated

K number K183051

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LJE 2019-05-17

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle

Applicant Cook Incorporated

K number K183035

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LJE 2019-03-27

Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set

Applicant Cook Incorporated

K number K181735

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LJE 2018-08-17

Ultraxx Nephrostomy Balloon Catheter Set

Applicant Cook Incorporated

K number K181713

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LJE 2018-02-23

Ultraxx Nephrostomy Balloon Catheter

Applicant Cook Incorporated

K number K171601

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LJE 2018-01-10

Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath

Applicant Boston Scientific Corporation

K number K172929

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LJE 2017-10-19

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

Applicant Cook Incorporated

K number K172527

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LJE 2016-07-12

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set

Applicant Jbw7 Innovations, LLC

K number K160077

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LJE 2012-09-18

NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER

Applicant Boston Scientific Corp

K number K121614

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LJE 2008-10-23

X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER

Applicant C.R. Bard, Inc.

K number K080944

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LJE 2007-01-05

X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER

Applicant C.R. Bard, Inc.

K number K063632

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LJE 2005-07-18

X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER

Applicant C.R. Bard, Inc.

K number K051316

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LJE 2003-02-27

COOK NEPHROSTOMY DILATION BALLOON CATHETER SET

Applicant Cook Urological, Inc.

K number K024050

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LJE 2001-11-16

RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS

Applicant Rusch Intl.

K number K011121

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LJE 1999-09-03

ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9

Applicant Zcv ,Inc.

K number K990689

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LJE 1998-09-10

URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING

Applicant Uresil Corp.

K number K981344

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LJE 1998-05-27

MANAN GENERAL UTILITY DRAINAGE CATHETER

Applicant Medical Device Technologies, Inc.

K number K980193

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LJE 1998-05-27

MANAN NEPHROSTOMY DRAINAGE CATHETER

Applicant Medical Device Technologies, Inc.

K number K980192

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LJE 1998-04-08

URESIL NEPHRO-URETERAL STENT

Applicant Uresil Corp.

K number K980889

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LJE 1996-07-18

CIRCLE NEPHROSTOMY CATHETER SET

Applicant Cook Urological, Inc.

K number K961933

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LJE 1996-03-26

MANAN GENERAL UTILITY DRAINAGE CATHETER

Applicant Manan Medical Products, Inc.

K number K953713

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LJE 1996-03-26

MANAN UNIVERSAL SUMP DRAINAGE CATHETER

Applicant Manan Medical Products, Inc.

K number K953601

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LJE 1995-08-30

MANAN NEPHROSTOMY DRAINAGE CATHETER

Applicant Manan Medical Products, Inc.

K number K953547

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LJE 1995-08-18

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K952887

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LJE 1995-08-10

DILATATION CATHETER, BALLOON

Applicant Boston Scientific Corp

K number K952968

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LJE 1995-06-06

NEPHRO-URETERAL STENT

Applicant Uresil Corp.

K number K942688

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LJE 1995-03-07

PERCUTANEOUS GRAINAGE CATHETER

Applicant Menlo Care, Inc.

K number K943893

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LJE 1992-11-10

MALECOT-NEPHROSTOMY TAMPONADE CATHETER

Applicant Cook Urological, Inc.

K number K915209

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LJE 1992-09-14

URESIL NEPHROSTOMY CATHETER

Applicant Uresil Corp.

K number K923097

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LJE 1992-09-14

URESIL SUMP DRAINAGE CATHETER

Applicant Uresil Corp.

K number K920509

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LJE 1989-04-07

BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET

Applicant Cook Urological, Inc.

K number K891406

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LJE 1986-10-31

NEPHROSTOMY SET

Applicant Meadox Surgimed, Inc.

K number K862742

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LJE 1985-03-07

MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET

Applicant Mentor Corp.

K number K850287

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LJE 1985-02-28

MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET

Applicant Mentor Corp.

K number K850286

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LJE 1985-01-15

NEPHROSTOMY DRAINAGE CATHETER & STIFFENER

Applicant American Edwards Laboratories

K number K845048

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LJE 1985-01-15

NEPHROSTOMY GUIDEWIRE SHEATH

Applicant American Edwards Laboratories

K number K845047

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LJE 1984-12-05

PERCUTANEOUS NEPHROSTOMY TROCAR SYS

Applicant American Edwards Laboratories

K number K844090

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LJE 1984-10-04

CURITY SILICONE NEPHROSTOMY CATHETER

Applicant The Kendal Co.

K number K842840

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LJE 1984-10-01

E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE

Applicant E-Z-Em, Inc.

K number K842121

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LJE 1984-09-10

CURITY SUPRAPUBIC DRAINAGE SYSTEM

Applicant The Kendal Co.

K number K842899

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LJE 1984-07-26

E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS

Applicant E-Z-Em, Inc.

K number K841720

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LJE 1984-02-10

PERCUTANEOUS RETROGRADE NEPHROSTOMY

Applicant Vpi

K number K833762

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LJE 1984-02-04

NEPHROSTOMY/BILIARY DRAINAGE BAG

Applicant Vertex Medical Corp.

K number K834476

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LJE 1983-10-19

PERCUTANEOUS NEPHROSTOMY CATHETER

Applicant Medical Engineering Corp.

K number K833008

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LJE 1983-05-05

URINARY DIVERSION STENT

Applicant Van-Tec, Inc.

K number K830803

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LJE 1983-02-09

SURGITEK PERCUTANEOUS NEPHROSTOMY CATH

Applicant Medical Engineering Corp.

K number K830226

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LJE 1983-01-28

NEPHROSTOMY CATHETER

Applicant Umi, Inc.

K number K823382

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LJE 1982-12-03

HEYER-SCHUTE UNIVERSAL URETERAL STENT

Applicant American Hospital Supply Corp.

K number K823418

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LJE 1982-08-10

SURGITEK PERCUTANEOUS NEPHROST. STENT

Applicant Medical Engineering Corp.

K number K821776

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