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FDA 510(k)

Disposable Cytology Brush BC-202D/203D Series

K-Number: K251279 · 2025-06-12

ApplicantOlympus Medical Systems Corporation
Decision Date2025-06-12
Product CodeBTG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Disposable Cytology Brush BC-202D/203D Series is a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-06-12 under approval number K251279. 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 Disposable Cytology Brush BC-202D/203D Series?

Disposable Cytology Brush BC-202D/203D Series is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K251279.

When was Disposable Cytology Brush BC-202D/203D Series approved by the FDA?

Disposable Cytology Brush BC-202D/203D Series received FDA 510(k) clearance on 2025-06-12, under approval number K251279.

What company makes Disposable Cytology Brush BC-202D/203D Series?

Disposable Cytology Brush BC-202D/203D Series is manufactured by Olympus Medical Systems Corporation.

What is the FDA product code for Disposable Cytology Brush BC-202D/203D Series?

The FDA product code for Disposable Cytology Brush BC-202D/203D Series is BTG.

Other Devices by Olympus Medical Systems Corporation

K211838Ultrasonic Bipolar Generator USG-410 with accessories K221557Visera Hysterovideoscope Olympus HYF Type V K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 K222584EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) K242357Water Container (MAJ-901); Water Container (MAJ-902)

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Related Devices (Code: BTG)

K190293Single Use Cytology Brush BC-205DOlympus Medical Systems Corp. K182927Pulmonary Cytology BrushHobbs 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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