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FDA 510(k)

Single Use Cytology Brush

K-Number: K220063 · 2022-07-28

ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Decision Date2022-07-28
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Cytology Brush is a medical device manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-28 under approval number K220063. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Cytology Brush?

Single Use Cytology Brush is a medical device that received FDA 510(k) clearance on 2022-07-28. It is manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K220063.

When was Single Use Cytology Brush approved by the FDA?

Single Use Cytology Brush received FDA 510(k) clearance on 2022-07-28, under approval number K220063.

What company makes Single Use Cytology Brush?

Single Use Cytology Brush is manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd..

What is the FDA product code for Single Use Cytology Brush?

The FDA product code for Single Use Cytology Brush is FDX.

Related Clinical Trials

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Other Devices by Zhejiang Chuangxiang Medical Technology Co., Ltd.

K173758Disposable Biopsy Valve K172762Single Use Hemoclip K172758Rotatable Snares, Non-Rotatable Snares K192258Disposable Valve Sets K191900Single Use Grasping Forceps K212669Single Use Hemoclip

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Related Devices (Code: FDX)

K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. K171607Bronchi and Gastrointestinal Cytology BrushWilson-Cook Medical Inc./Cook Endoscopy K172663Cytology BrushMicro-Tech (Nanjing) Co., Ltd. K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc. K191485Deflectable Brush Biopsy SetCook Incorporated K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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