Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Stone Retrieval Balloon Catheter

K-Number: K253013 · 2026-05-08

ApplicantZhejiang Soudon Medical Technology Co., Ltd.
Decision Date2026-05-08
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Stone Retrieval Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K253013. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Stone Retrieval Balloon Catheter?

Disposable Stone Retrieval Balloon Catheter is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. The 510(k) number is K253013.

When did Disposable Stone Retrieval Balloon Catheter receive FDA 510(k) clearance?

Disposable Stone Retrieval Balloon Catheter received FDA 510(k) clearance on 2026-05-08, under 510(k) number K253013.

Who is the listed applicant for Disposable Stone Retrieval Balloon Catheter?

The FDA 510(k) record lists Zhejiang Soudon Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Stone Retrieval Balloon Catheter?

The FDA product code for Disposable Stone Retrieval Balloon Catheter is GCA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06798753Occlusion Balloon vs. 5FR Ureteral CatheterCOMPLETEDNCT07743528A Prospective, Multicenter, Two-cohorts, Single Arm Study Evaluating Safety, Effectiveness and Performance of Angimis Atherectomy System for the Treatment of Non-crossable and/or Non-dilatablE Lesions in CorONary Arteries Disease (NEON Study).NOT_YET_RECRUITING

Other records listing Zhejiang Soudon Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253056Disposable Stone Extraction BasketK232450Disposable Hemostatic ClipsK232442Disposable Endoscope Injection NeedlesK232476Disposable Sphincterotome

Related Devices (Code: GCA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)Jiangsu Vedkang Medical Science and Technology Co., Ltd.K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific CorporationK210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd.K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd.K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, Inc.K193344Tri-Ex Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑