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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 the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-28 under 510(k) 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. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K220063.

When did Single Use Cytology Brush receive FDA 510(k) clearance?

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

Who is the listed applicant for Single Use Cytology Brush?

The FDA 510(k) record lists Zhejiang Chuangxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Zhejiang Chuangxiang Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems CorporationK192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.K191485Deflectable Brush Biopsy SetCook IncorporatedK182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook IncorporatedK181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.K172663Cytology BrushMicro-Tech (Nanjing) Co., Ltd.

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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