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FDA 510(k)

Cytology Brush

K-Number: K172663 · 2018-03-05

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2018-03-05
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Cytology Brush is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2018-03-05 under approval 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. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K172663.

When was Cytology Brush approved by the FDA?

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

What company makes Cytology Brush?

Cytology Brush is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Cytology Brush?

The FDA product code for Cytology Brush is FDX.

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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 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

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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