Cleared Traditional

Disposable ureteral stent

K243830 · Shenzhen Trious Medical Technology Co., Ltd. · Gastroenterology & Urology
May 2025
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K243830 is an FDA 510(k) clearance for the Disposable ureteral stent, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Shenzhen Trious Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 14, 2025, 152 days after receiving the submission on December 13, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.

Submission Details

510(k) Number K243830 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2024
Decision Date May 14, 2025
Days to Decision 152 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FAD — Stent, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4620

Similar Devices — FAD Stent, Ureteral

All 121
Disposable Ureteral Stents
K251890 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Feb 2026
Endura? Ureteral Stent and Stent Set
K251469 · Cathegenix (Xiamen) Co., Ltd. · Dec 2025
Ureteral Stents (AF-D series)
K243039 · Alton (Shanghai) Medical Instruments Co., Ltd. · Jun 2025
Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
K250824 · Boston Scientific Corporation · Apr 2025
RELIEF? Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF? Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
K232920 · Ureteral Stent Company · Mar 2024
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
K211934 · Boston Scientific Corporation · Nov 2022