Cleared Traditional

Disposable Percutaneous Nephrostomy Dilatation Kit

K250448 · Shenzhen Trious Medical Technology Co., Ltd. · Gastroenterology & Urology
Jul 2025
Decision
135d
Days
—
Risk

About This 510(k) Submission

K250448 is an FDA 510(k) clearance for the Disposable Percutaneous Nephrostomy Dilatation Kit, a Catheter, Nephrostomy, submitted by Shenzhen Trious Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 3, 2025, 135 days after receiving the submission on February 18, 2025. This device falls under the Gastroenterology & Urology review panel.

Submission Details

510(k) Number K250448 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2025
Decision Date July 03, 2025
Days to Decision 135 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code LJE — Catheter, Nephrostomy
Device Class —

Similar Devices — LJE Catheter, Nephrostomy

All 55
Introducer Needle
K222705 · Youcare Technology Co.,Ltd. (Wuhan) · May 2023
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
K211911 · Coloplast Corp. · Mar 2022
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
K201165 · Coloplast Corp. · Dec 2020
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
K191498 · Cook Incorporated · Jan 2020
Lawson Retrograde Nephrostomy Wire Puncture Set
K190903 · Cook Incorporated · Dec 2019
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
K183051 · Cook Incorporated · Jul 2019