510(k) K250448

Device
Disposable Percutaneous Nephrostomy Dilatation Kit
Applicant
Shenzhen Trious Medical Technology Co., Ltd.
510(k) number
K250448
Product code
LJE
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-03
Date received
2025-02-18
Classification name
Catheter, Nephrostomy
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Yi Yingfang
Address
Rm.102-2, Longtian Tongfuyu Ind Estate #11-3, And Rm.401 & 402, Bldg. D3, Yingzhan S&T Estate, Longtian Tongfuyu Rd. #8 Shenzhen CN

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LJE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan)2023-05-22
K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.2022-03-10
K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.2020-12-17
K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook Incorporated2020-01-29
K190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated2019-12-16
K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated2019-07-16
K183035Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar NeedleCook Incorporated2019-05-17
K181735Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetCook Incorporated2019-03-27
K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated2018-08-17
K171601Ultraxx Nephrostomy Balloon CatheterCook Incorporated2018-02-23
K172929Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal SheathBoston Scientific Corporation2018-01-10
K172527Amplatz 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 StripeCook Incorporated2017-10-19
K160077RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture SetJbw7 Innovations, LLC2016-07-12
K132383GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETERGyrus Acmi, Inc.2014-02-04
K121614NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETERBoston Scientific Corp2012-09-18