Disposable Percutaneous Nephrostomy Dilatation Kit

Q: What is the product code of K250448?

The FDA product code is LJE – Catheter, Nephrostomy, a Unclassified device.

FDA 510(k) K250448 · Shenzhen Trious Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK250448

Submission

Device name: Disposable Percutaneous Nephrostomy Dilatation Kit
Applicant: Shenzhen Trious Medical Technology Co., Ltd.
Shenzhen, CN
Received: February 18, 2025
Decision date: July 3, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LJE – Catheter, Nephrostomy
Device class: Unclassified

Other 510(k)s with product code LJE

510(k)	Device	Applicant	Decision
K222705	Introducer NeedleLJE · Traditional	Youcare Technology Co.,Ltd. (Wuhan)	05/22/2023SE
K211911	Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits…LJE · Traditional	Coloplast Corp.	03/10/2022SESK
K201165	In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathLJE · Traditional	Coloplast Corp.	12/17/2020SESK
K191498	Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional	Cook Incorporated	01/29/2020SESK
K190903	Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional	Cook Incorporated	12/16/2019SE
K183051	Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetLJE · Traditional	Cook Incorporated	07/16/2019SESK
K183035	Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar NeedleLJE · Traditional	Cook Incorporated	05/17/2019SESK
K181735	Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetLJE · Traditional	Cook Incorporated	03/27/2019SESK
K181713	Ultraxx Nephrostomy Balloon Catheter SetLJE · Traditional	Cook Incorporated	08/17/2018SE
K171601	Ultraxx Nephrostomy Balloon CatheterLJE · Traditional	Cook Incorporated	02/23/2018SE

More from Cook Incorporated

510(k)	Device	Decision
K243830	Disposable ureteral stentFAD · Traditional	05/14/2025SE
K243710	Disposable ureteral access sheathFED · Traditional	04/11/2025SE

Questions and answers

When was Disposable Percutaneous Nephrostomy Dilatation Kit cleared by the FDA?

Disposable Percutaneous Nephrostomy Dilatation Kit (K250448) received a 510(k) decision of Substantially Equivalent on July 3, 2025, 135 days after the submission was received.

What is the product code of K250448?

The FDA product code is LJE – Catheter, Nephrostomy, a Unclassified device.