Product Code: FDX FDA class 2 21 CFR 876.1500

Endoscopic Cytology Brush

Gastroenterology, Urology

The Endoscopic Cytology Brush (product code FDX) is a brush-tipped device passed through an endoscope to collect cells from the mucosal surface of the gastrointestinal or genitourinary tract for cytological evaluation and cancer screening. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: FDX
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

To collect cells for cytological evaluation.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 44 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250993	Single Use Cytology Brush V (BC-V600P-3010)	Dec 18, 2025	Substantially Equivalent	Olympus Medical Systems Corporation
K220063	Single Use Cytology Brush	Jul 28, 2022	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.
K192908	Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes	Nov 14, 2019	Substantially Equivalent	Wilson-Cook Medical, Inc.
K191485	Deflectable Brush Biopsy Set	Jun 26, 2019	Substantially Equivalent	Cook Incorporated
K182231	Brush Biopsy Set ; Deflectable Brush Biopsy Set	May 01, 2019	Substantially Equivalent	Cook Incorporated
K181317	Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush	Feb 08, 2019	Substantially Equivalent	Wilson-Cook Medical, Inc.
K172663	Cytology Brush	Mar 05, 2018	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K171573	Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush	Dec 29, 2017	Substantially Equivalent	Wilson-Cook Medical, Inc.
K171607	Bronchi and Gastrointestinal Cytology Brush	Jul 31, 2017	Substantially Equivalent	Wilson-Cook Medical Inc./Cook Endoscopy
K151889	Infinity ERCP Sampling Device	Jul 30, 2015	Substantially Equivalent	United States Endoscopy Group, Inc.
K103437	US ENDOSCOPY CYTOLOGY BRUSH	Dec 23, 2010	Substantially Equivalent	United States Endoscopy Group, Inc.
K052279	COOK IRELAND ECHOBRUSH	Oct 11, 2005	Substantially Equivalent	Cook Ireland, Ltd.
K040324	WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH	May 20, 2004	Substantially Equivalent	Wilson-Cook Medical, Inc.
K021998	HORIZONS CYTOLOGY BRUSH	Jul 12, 2002	Substantially Equivalent	Horizons Intl. Corp.
K965037	CELL RECOVERY SYSTEM	Jan 08, 1997	Substantially Equivalent	Medical Device Technologies, Inc.
K960004	CELL RECOVERY SYSTEM	Mar 20, 1996	Substantially Equivalent	Medical Device Technologies, Inc.
K954121	CYTOLOGY BRUSH	Oct 07, 1995	Substantially Equivalent	Lighthouse Medical, Inc.
K944614	MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM	Apr 05, 1995	Substantially Equivalent	Biosearch Medical Products, Inc.
K942144	URETHRA-BRUSH	Jun 27, 1994	Substantially Equivalent	Rovers Diagnostic Devices
K930348	COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM	Sep 03, 1993	Substantially Equivalent	Boston Scientific Corp
K923200	AMCATH DISPOSABLE CYTOLOGY BRUSH	Dec 07, 1992	Substantially Equivalent	Intl. Medical, Inc.
K924104	CYTOLOGY BRUSH	Nov 24, 1992	Substantially Equivalent	United States Endoscopy Group, Inc.
K922851	CYTOLOGY BRUSH	Aug 25, 1992	Substantially Equivalent	Annex Medical, Inc.
K914504	CYTOLOGY BRUSH	Feb 18, 1992	Substantially Equivalent	Surgitek Medical Engineering Corp.
K914466	COX DISPOSABLE CYTOLOGY BRUSHES	Oct 25, 1991	Substantially Equivalent	Cox Medical Ent., Inc.
K913248	CYTOLOGY BRUSH	Sep 30, 1991	Substantially Equivalent	Annex Medical, Inc.
K912407	COX DISPOSABLE CYTOLOGY BRUSHES	Sep 10, 1991	Substantially Equivalent	Cox Medical Ent., Inc.
K911481	LAPAROSCOPIC CLEANING BRUSH INSTRUMENT	Apr 22, 1991	Substantially Equivalent	United States Endoscopy Group, Inc.
K902737	BC BRUSHES	Aug 24, 1990	Substantially Equivalent	Olympus Corp.
K901435	GASTROINTESTINAL CYTOLOGY BRUSH	Jul 16, 1990	Substantially Equivalent	Telemed Systems, Inc.
K901436	BRONCHIAL CYTOLOGY BRUSH	Jun 18, 1990	Substantially Equivalent	Telemed Systems, Inc.
K896318	WILSON-COOK CYTOLOGY BRUSHES	Apr 09, 1990	Substantially Equivalent	Wilson-Cook Medical, Inc.
K896425	PORGES CYTOLOGY BRUSHES	Jan 29, 1990	Substantially Equivalent	Porges Corp.
K894863	WILTEK CYTOLOGY BRUSH	Dec 21, 1989	Substantially Equivalent	Wiltek Medical, Inc.
K893729	HOBBS MEDICAL MICROBIOLOGY BRUSH	Aug 28, 1989	Substantially Equivalent	Hobbs Medical, Inc.
K880095	BERGER PROSTATE CULTURE CYTOLOGY BRUSH	Mar 02, 1988	Substantially Equivalent	Van-Tec, Inc.
K860997	GASTROINTESTINAL CYTOLOGY BRUSH	May 02, 1986	Substantially Equivalent	Endovations
K853530	ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH	Oct 04, 1985	Substantially Equivalent	E-Z-Em, Inc.
K844561	BARD URETEROSCOPIC CYTOLOGY BRUSH	Jan 08, 1985	Substantially Equivalent	C.R. Bard, Inc.
K834402	GASTROINTESTINAL SHEATH BRUSH	Feb 04, 1984	Substantially Equivalent	Hobbs Medical, Inc.
K833330	MUTO BRUSH	Nov 14, 1983	Substantially Equivalent	Microvasive
K800966	M.R. ASSOC. CYTOLOGY BRUSHES	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K791668	ENDOSCOPIC CYTOLOGY BRUSHES	Oct 01, 1979	Substantially Equivalent	Mill-Rose Laboratory
K770913	UROLOGICAL BIOPSY BRUSH SET	Jun 01, 1977	Substantially Equivalent	Cook, Inc.