FDA 510(k)

Cytology Brush

K-Number: K172663 · 2018-03-05

Decision Date2018-03-05

Product CodeFDX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Cytology Brush is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2018-03-05 under 510(k) number K172663. 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 Cytology Brush?

Cytology Brush is a medical device that received FDA 510(k) clearance on 2018-03-05. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K172663.

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

Cytology Brush received FDA 510(k) clearance on 2018-03-05, under 510(k) number K172663.

Who is the listed applicant for Cytology Brush?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cytology Brush?

The FDA product code for Cytology Brush is FDX.

Other records listing Micro-Tech (Nanjing) Co., Ltd. as applicant

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Related Devices (Code: FDX)

K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation K220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology 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 K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.

Official Source

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