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FDA 510(k)

Single Use Cytology Brush BC-205D

K-Number: K190293 · 2019-08-02

Decision Date2019-08-02
Product CodeBTG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Single Use Cytology Brush BC-205D is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) 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. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K190293.

When did Single Use Cytology Brush BC-205D receive FDA 510(k) clearance?

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

Who is the listed applicant for Single Use Cytology Brush BC-205D?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Olympus Medical Systems Corp. 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.

View all 112 devices →

Related Devices (Code: BTG)

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.

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.