Ureteral Access Sheath— 510(k) K243025

Substantially Equivalent

Seplou (Zhuhai) Co., Ltd.

FDA 510(k) clearance K243025 for Ureteral Access Sheath, Substantially Equivalent on 2025-01-30. Applicant: Seplou (Zhuhai) Co., Ltd..

Clearance details

Applicant: Seplou (Zhuhai) Co., Ltd.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-27
Decision date: 2025-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai, 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.