Cleared Traditional

Single Use Cytology Brush BC-205D

K190293 · Olympus Medical Systems Corp. · Anesthesiology

Aug 2019

Decision

172d

Days

Class 2

Risk

About This 510(k) Submission

K190293 is an FDA 510(k) clearance for the Single Use Cytology Brush BC-205D, a Brush, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BTG), submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on August 2, 2019, 172 days after receiving the submission on February 11, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K190293 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2019
Decision Date	August 02, 2019
Days to Decision	172 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).