510(k) K230748— Disposable Ureteral Access Sheath

Substantially Equivalent

Youcare Technology Co.,Ltd. (Wuhan)

Clearance details

Applicant: Youcare Technology Co.,Ltd. (Wuhan)
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2023-03-17
Decision date: 2023-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, CN

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.