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FDA 510(k)

Single Use Cytology Brush BC-205D

K-Number: K190293 · 2019-08-02

ApplicantOlympus Medical Systems Corp.
Decision Date2019-08-02
Product CodeBTG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Single Use Cytology Brush BC-205D is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-08-02 under approval number K190293. The device is classified under product code BTG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Cytology Brush BC-205D?

Single Use Cytology Brush BC-205D is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K190293.

When was Single Use Cytology Brush BC-205D approved by the FDA?

Single Use Cytology Brush BC-205D received FDA 510(k) clearance on 2019-08-02, under approval number K190293.

What company makes Single Use Cytology Brush BC-205D?

Single Use Cytology Brush BC-205D is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single Use Cytology Brush BC-205D?

The FDA product code for Single Use Cytology Brush BC-205D is BTG.

Related Clinical Trials

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Related Devices (Code: BTG)

K182927Pulmonary Cytology BrushHobbs Medical, Inc. K251279Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation

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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