DeviceClearance

Single use stone retrieval balloons— 510(k) K253132

Substantially Equivalent

Zhejiang Chuangxiang Medical Technology Co., Ltd.

FDA 510(k) clearance K253132 for Single use stone retrieval balloons, Substantially Equivalent on 2026-03-06. Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Device class: 2.

Summary

Zhejiang Chuangxiang Medical Technology's Single use stone retrieval balloons are filed under FGE, biliary duct stents, drains and dilators. The name is generic, and the record doesn't list sizes or models.

Class II, 21 CFR 876.5010. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).

Zhejiang Chuangxiang Medical Technology filed from Hangzhou, China. The decision came 162 calendar days after receipt (September 25, 2025 to March 6, 2026).

Clearance details

Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product code
Product code FGE
Device class
Class 2
Regulation
21 CFR 876.5010
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou, CN
Download summary PDFView on FDA.gov ↗

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More clearances from Zhejiang Chuangxiang Medical Technology Co., Ltd.

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Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.