Disposable ureteral stent

FDA 510(k) K243830 · Shenzhen Trious Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK243830

Submission

Device name
Disposable ureteral stent
Applicant
Shenzhen Trious Medical Technology Co., Ltd.
Shenzhen, CN
Received
December 13, 2024
Decision date
May 14, 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
FAD – Stent, Ureteral
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4620
Specialty
Gastroenterology, Urology
Implant
Yes

Other 510(k)s with product code FAD

510(k)DeviceApplicantDecision
K251890Disposable Ureteral StentsFAD · Traditional Zhejiang Chuangxiang Medical Technology Co., Ltd.02/20/2026SE
K251469Endura™ Ureteral Stent and Stent SetFAD · Traditional Cathegenix (Xiamen) Co., Ltd.12/19/2025SESK
K243039Ureteral Stents (AF-D series)FAD · Traditional Alton (Shanghai) Medical Instruments Co., Ltd.06/18/2025SE
K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…FAD · Special Boston Scientific Corporation04/15/2025SE
K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit…FAD · Traditional Ureteral Stent Company03/22/2024SE
K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…FAD · Traditional Boston Scientific Corporation11/10/2022SESK
K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…FAD · Traditional Coloplast Corp.06/08/2022SESK
K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional Ureteral Stent Company03/17/2022SE
K213186NovoFlow Reinforced Ureteral StentFAD · Traditional Coloplast Corp.02/16/2022SESK
K212868JFil Ureteral Stents, JFil Ureteral Stents ECO KITFAD · Traditional Rocamed Sam01/26/2022SE

More from Rocamed Sam

510(k)DeviceDecision
K250448Disposable Percutaneous Nephrostomy Dilatation KitLJE · Traditional 07/03/2025SE
K243710Disposable ureteral access sheathFED · Traditional 04/11/2025SE

Questions and answers

When was Disposable ureteral stent cleared by the FDA?

Disposable ureteral stent (K243830) received a 510(k) decision of Substantially Equivalent on May 14, 2025, 152 days after the submission was received.

What is the product code of K243830?

The FDA product code is FAD – Stent, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4620.