LJE — Catheter, Nephrostomy Class U

FDA Device Classification

Classification Details

Product Code
LJE
Device Class
Class U
Regulation Number
Submission Type
Review Panel
GU
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250448shenzhen trious medical technology coDisposable Percutaneous Nephrostomy Dilatation KitJuly 3, 2025
K222705youcare technology co.,ltd. (wuhan)Introducer NeedleMay 22, 2023
K211911coloplastKolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy KitMarch 10, 2022
K201165coloplastIn-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathDecember 17, 2020
K191498cook incorporatedCook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, UltrathJanuary 29, 2020
K190903cook incorporatedLawson Retrograde Nephrostomy Wire Puncture SetDecember 16, 2019
K183051cook incorporatedKaye Nephrostomy Tamponade Balloon Catheter and Stent SetJuly 16, 2019
K183035cook incorporatedPercutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part TroMay 17, 2019
K181735cook incorporatedPercutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetMarch 27, 2019
K181713cook incorporatedUltraxx Nephrostomy Balloon Catheter SetAugust 17, 2018
K171601cook incorporatedUltraxx Nephrostomy Balloon CatheterFebruary 23, 2018
K172929boston scientific corporationAmplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal SheatJanuary 10, 2018
K172527cook incorporatedAmplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, AmplOctober 19, 2017
K160077jbw7 innovationsRetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture SetJuly 12, 2016
K132383gyrus acmiGYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETERFebruary 4, 2014
K121614boston scientificNEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETERSeptember 18, 2012
K080944c.r. bardX-FORCE NEPHROSTOMY BALLOON DILATION CATHETEROctober 23, 2008
K063632c.r. bardX-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETERJanuary 5, 2007
K051316c.r. bardX-FORCE NEPHROSTOMY BALLOON DILATION CATHETERJuly 18, 2005
K024050cook urologicalCOOK NEPHROSTOMY DILATION BALLOON CATHETER SETFebruary 27, 2003