Ureteral Access Sheath— 510(k) K250132

Name: FDA 510(k) clearance K250132
Creator: U.S. Food and Drug Administration
Published: 2025-09-05

Substantially Equivalent

Zhejiang YiGao Medical Technology Co., Ltd.

FDA 510(k) clearance K250132 for Ureteral Access Sheath, Substantially Equivalent on 2025-09-05. Applicant: Zhejiang YiGao Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang YiGao Medical Technology Co., Ltd.
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-17
Decision date: 2025-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FED

view all

K260410 — Single Use Ureteral Access Sheath2026-09-11
K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
K260965 — CVAC Aspiration System2026-04-13
K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)2026-04-06
K252572 — Prodeon Urethral Sheath System2025-10-07

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.