FDA.reportPublic FDA data

510(k) K250993

Device
Single Use Cytology Brush V (BC-V600P-3010)
Applicant
Olympus Medical Systems Corporation
510(k) number
K250993
Product code
FDX
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-18
Date received
2025-03-31
Regulation
876.1500
Classification name
Endoscopic Cytology Brush
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eve Smith
Address
2951 Ishikawa-Cho Hachioji-Shi JP 192-8507 192-8507

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FDX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.2022-07-28
K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.2019-11-14
K191485Deflectable Brush Biopsy SetCook Incorporated2019-06-26
K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated2019-05-01
K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.2019-02-08
K172663Cytology BrushMicro-Tech (Nanjing) Co., Ltd.2018-03-05
K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.2017-12-29
K171607Bronchi and Gastrointestinal Cytology BrushWilson-Cook Medical Inc./Cook Endoscopy2017-07-31
K151889Infinity ERCP Sampling DeviceUnited States Endoscopy Group, Inc.2015-07-30
K103437US ENDOSCOPY CYTOLOGY BRUSHUnited States Endoscopy Group, Inc.2010-12-23
K052279COOK IRELAND ECHOBRUSHCook Ireland, Ltd.2005-10-11
K040324WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSHWilson-Cook Medical, Inc.2004-05-20
K021998HORIZONS CYTOLOGY BRUSHHorizons Intl. Corp.2002-07-12
K965037CELL RECOVERY SYSTEMMedical Device Technologies, Inc.1997-01-08
K960004CELL RECOVERY SYSTEMMedical Device Technologies, Inc.1996-03-20