K222677

Substantially Equivalent

Intermittent nelaton catheter for single use

Applicant: Hangzhou Jimushi Meditech Co., Ltd.
Product code: EZD
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-06
Decision date: 2023-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.