Yikang Latex Foley Catheter— 510(k) K173340

Substantially Equivalent

Jiangxi Yikang Medical Instrument Group Co., Ltd.

FDA 510(k) clearance K173340 for Yikang Latex Foley Catheter, Substantially Equivalent on 2018-07-13. Applicant: Jiangxi Yikang Medical Instrument Group Co., Ltd..

Clearance details

Applicant: Jiangxi Yikang Medical Instrument Group Co., Ltd.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2017-10-23
Decision date: 2018-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanchang, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.