Disposable Stone Retrieval Balloon Catheter

Q: What is the product code of K253013?

The FDA product code is GCA – Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, a Class II (moderate risk) device regulated under 21 CFR 876.5010.

FDA 510(k) K253013 · Zhejiang Soudon Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK253013

Submission

Device name: Disposable Stone Retrieval Balloon Catheter
Applicant: Zhejiang Soudon Medical Technology Co., Ltd.
Hangzhou, CN
Received: September 19, 2025
Decision date: May 8, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GCA – Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5010
Specialty: Gastroenterology, Urology

Other 510(k)s with product code GCA

510(k)	Device	Applicant	Decision
K232752	Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-…GCA · Traditional	Jiangsu Vedkang Medical Science and Technology…	02/26/2024SE
K212582	SpyGlass Discover Balloon Dilation CatheterGCA · Traditional	Boston Scientific Corporation	05/06/2022SE
K210660	Stone Retrieval Balloon CatheterGCA · Traditional	Anrei Medical (Hangzhou) Co., Ltd.	04/27/2021SE
K200173	Stone Retrieval BalloonGCA · Traditional	Hangzhou AGS MedTech Co., Ltd.	05/01/2020SE
K200247	Fusion Quattro Extraction BalloonGCA · Special	Wilson-Cook Medical, Inc.	02/27/2020SE
K193344	Tri-Ex Extraction Balloon with Multiple SizingGCA · Special	Wilson-Cook Medical, Inc.	12/13/2019SE
K173659	Howell D.A.S.H Extraction Balloon with Multiple SizingGCA · Special	Wilson-Cook Medical, Inc.	07/06/2018SE
K173414	Advance Biliary Balloon CatheterGCA · Traditional	Cook Incorporated	06/22/2018SESK
K170292	Tri-Ex Extraction Balloon With Multiple SizingGCA · Special	Wilson-Cook Medical, Inc.	09/20/2017SE
K063677	Fusion Quattro Extraction Balloon XLGCA · Special	Wilson-Cook Medical, Inc.	01/05/2007SE

More from Wilson-Cook Medical, Inc.

510(k)	Device	Decision
K253056	Disposable Stone Extraction BasketLQR · Traditional	04/03/2026SE
K232450	Disposable Hemostatic ClipsPKL · Traditional	01/26/2024SE
K232442	Disposable Endoscope Injection NeedlesFBK · Traditional	11/09/2023SE
K232476	Disposable SphincterotomeKNS · Traditional	11/07/2023SE

Questions and answers

When was Disposable Stone Retrieval Balloon Catheter cleared by the FDA?

Disposable Stone Retrieval Balloon Catheter (K253013) received a 510(k) decision of Substantially Equivalent on May 8, 2026, 231 days after the submission was received.

What is the product code of K253013?

The FDA product code is GCA – Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, a Class II (moderate risk) device regulated under 21 CFR 876.5010.