Single Use Suction-Evacuation Ureteral Access Sheath— 510(k) K250128

Substantially Equivalent

Anhui Happiness Workshop Medical Instruments Co., Ltd.

FDA 510(k) clearance K250128 for Single Use Suction-Evacuation Ureteral Access Sheath, Substantially Equivalent on 2025-09-19. Applicant: Anhui Happiness Workshop Medical Instruments Co., Ltd..

Clearance details

Applicant: Anhui Happiness Workshop Medical Instruments Co., Ltd.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-17
Decision date: 2025-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bengbu, CN

Download summary PDF View on FDA.gov ↗

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.