Cleared Traditional

Disposable Cytology Brush BC-202D/203D Series

K251279 · Olympus Medical Systems Corporation · Anesthesiology

Jun 2025

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K251279 is an FDA 510(k) clearance for the Disposable Cytology Brush BC-202D/203D Series, a Brush, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BTG), submitted by Olympus Medical Systems Corporation (Hachiochi-Shi, JP). The FDA issued a Cleared decision on June 12, 2025, 49 days after receiving the submission on April 24, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K251279 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2025
Decision Date	June 12, 2025
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	BTG — Brush, Biopsy, Bronchoscope (non-rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).