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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 a medical device manufactured by Zhejiang Soudon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-08 under approval 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. It is manufactured by Zhejiang Soudon Medical Technology Co., Ltd.. The 510(k) number is K253013.

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

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

What company makes Disposable Stone Retrieval Balloon Catheter?

Disposable Stone Retrieval Balloon Catheter is manufactured by Zhejiang Soudon Medical Technology Co., Ltd..

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

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

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.

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