Single Use Cytology Brush— 510(k) K220063

Name: FDA 510(k) clearance K220063
Creator: U.S. Food and Drug Administration
Published: 2022-07-28

Substantially Equivalent

Zhejiang Chuangxiang Medical Technology Co., Ltd.

FDA 510(k) clearance K220063 for Single Use Cytology Brush, Substantially Equivalent on 2022-07-28. Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-01-10
Decision date: 2022-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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