Single Use Ureteral Access Sheath— 510(k) K220065

Name: FDA 510(k) clearance K220065
Creator: U.S. Food and Drug Administration
Published: 2022-05-25

Substantially Equivalent

Zhejiang Chuangxiang Medical Technology Co., Ltd.

FDA 510(k) clearance K220065 for Single Use Ureteral Access Sheath, Substantially Equivalent on 2022-05-25. Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-01-10
Decision date: 2022-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FED

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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

More clearances from Zhejiang Chuangxiang Medical Technology Co., Ltd.

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K253132 — Single use stone retrieval balloons2026-03-06
K251890 — Disposable Ureteral Stents2026-02-20
K230773 — Endoscopy Irrigation Tubing2023-11-21
K231471 — Air/Water Bottle Tubing, CO2 Source Tubing2023-09-08
K220063 — Single Use Cytology Brush2022-07-28

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.