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FDA 510(k)

Single use stone retrieval balloons

K-Number: K253132 · 2026-03-06

ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Decision Date2026-03-06
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single use stone retrieval balloons is a medical device manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-06 under approval number K253132. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single use stone retrieval balloons?

Single use stone retrieval balloons is a medical device that received FDA 510(k) clearance on 2026-03-06. It is manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K253132.

When was Single use stone retrieval balloons approved by the FDA?

Single use stone retrieval balloons received FDA 510(k) clearance on 2026-03-06, under approval number K253132.

What company makes Single use stone retrieval balloons?

Single use stone retrieval balloons is manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd..

What is the FDA product code for Single use stone retrieval balloons?

The FDA product code for Single use stone retrieval balloons is FGE.

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Other Devices by Zhejiang Chuangxiang Medical Technology Co., Ltd.

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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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