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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 the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-06-12 under 510(k) 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. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K251279.

When did Disposable Cytology Brush BC-202D/203D Series receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Cytology Brush BC-202D/203D Series?

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

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 records listing Olympus Medical Systems Corporation 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.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)K261260HD Camera Head OLYMPUS CH-S200-08-LBK260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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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.

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

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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