Rotatable Snares, Non-Rotatable Snares— 510(k) K172758

Substantially Equivalent

Zhejiang Chuangxiang Medical Technology Co., Ltd.

FDA 510(k) clearance K172758 for Rotatable Snares, Non-Rotatable Snares, Substantially Equivalent on 2018-03-07. Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd..

Clearance details

Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product code: Code FDI
Advisory panel: Gastroenterology, Urology
Date received: 2017-09-13
Decision date: 2018-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.