FDX · Class II · 21 CFR 876.1500

FDA Product Code FDX: Endoscopic Cytology Brush

To Collect Cells For Cytological Evaluation.

Leading manufacturers include Wilson-Cook Medical, Inc., United States Endoscopy Group, Inc. and Telemed Systems, Inc..

44
Total
44
Cleared
93d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 262d recently vs 89d historically

FDA 510(k) Cleared Endoscopic Cytology Brush Devices (Product Code FDX)

44 devices
1–24 of 44
Cleared Dec 18, 2025
Single Use Cytology Brush V (BC-V600P-3010)
K250993
Olympus Medical Systems Corporation
Gastroenterology & Urology · 262d
Cleared Jul 28, 2022
Single Use Cytology Brush
K220063
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Gastroenterology & Urology · 199d
Cleared Nov 14, 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
K192908
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 26, 2019
Deflectable Brush Biopsy Set
K191485
Cook Incorporated
Gastroenterology & Urology · 22d
Cleared May 01, 2019
Brush Biopsy Set
K182231
Cook Incorporated
Gastroenterology & Urology · 257d
Cleared Feb 08, 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K181317
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 266d
Cleared Mar 05, 2018
Cytology Brush
K172663
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 181d
Cleared Dec 29, 2017
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 213d
Cleared Jul 31, 2017
Bronchi and Gastrointestinal Cytology Brush
K171607
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 60d
Cleared Jul 30, 2015
Infinity ERCP Sampling Device
K151889
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 23, 2010
US ENDOSCOPY CYTOLOGY BRUSH
K103437
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 11, 2005
COOK IRELAND ECHOBRUSH
K052279
Cook Ireland, Ltd.
Gastroenterology & Urology · 50d
Cleared May 20, 2004
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
K040324
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 100d
Cleared Jan 08, 1997
CELL RECOVERY SYSTEM
K965037
Medical Device Technologies, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 20, 1996
CELL RECOVERY SYSTEM
K960004
Medical Device Technologies, Inc.
Gastroenterology & Urology · 78d
Cleared Apr 05, 1995
MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
K944614
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 197d
Cleared Sep 03, 1993
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
K930348
Boston Scientific Corp
Gastroenterology & Urology · 221d
Cleared Dec 07, 1992
AMCATH DISPOSABLE CYTOLOGY BRUSH
K923200
Intl. Medical, Inc.
Gastroenterology & Urology · 160d
Cleared Nov 24, 1992
CYTOLOGY BRUSH
K924104
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 103d
Cleared Aug 25, 1992
CYTOLOGY BRUSH
K922851
Annex Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Sep 30, 1991
CYTOLOGY BRUSH
K913248
Annex Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 22, 1991
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
K911481
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 18d
Cleared Aug 24, 1990
BC BRUSHES
K902737
Olympus Corp.
Gastroenterology & Urology · 64d
Cleared Jul 16, 1990
GASTROINTESTINAL CYTOLOGY BRUSH
K901435
Telemed Systems, Inc.
Gastroenterology & Urology · 112d

About Product Code FDX - Regulatory Context

510(k) Submission Activity

44 total 510(k) submissions under product code FDX since 1977, with 44 receiving FDA clearance (average review time: 93 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FDX Product Code

Recent submissions under FDX have taken an average of 262 days to reach a decision - up from 89 days historically. Manufacturers should account for longer review timelines in current project planning.

FDX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →