K260521

Substantially Equivalent

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
Product code: FED
Advisory panel: Gastroenterology, Urology
Date received: 2026-02-17
Decision date: 2026-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai, 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.