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

Clearance details

Applicant

Zhejiang Chuangxiang Medical Technology Co., Ltd.

Product code

Code FDI

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2017-09-13

Decision date

2018-03-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hanzhou, CN

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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 →