Endoscopic Cytology Brush

FDA product code FDX · 43 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1500
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-06-01 – 2025-12-18

To collect cells for cytological evaluation.

FDX 2025-12-18

Single Use Cytology Brush V (BC-V600P-3010)

Applicant Olympus Medical Systems Corporation

K number K250993

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FDX 2022-07-28

Single Use Cytology Brush

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K number K220063

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FDX 2019-11-14

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes

Applicant Wilson-Cook Medical, Inc.

K number K192908

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FDX 2019-06-26

Deflectable Brush Biopsy Set

Applicant Cook Incorporated

K number K191485

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FDX 2019-05-01

Brush Biopsy Set ; Deflectable Brush Biopsy Set

Applicant Cook Incorporated

K number K182231

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FDX 2019-02-08

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

Applicant Wilson-Cook Medical, Inc.

K number K181317

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FDX 2018-03-05

Cytology Brush

Applicant Micro-Tech (Nanjing) Co., Ltd.

K number K172663

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FDX 2017-12-29

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

Applicant Wilson-Cook Medical, Inc.

K number K171573

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FDX 2017-07-31

Bronchi and Gastrointestinal Cytology Brush

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K number K171607

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FDX 2010-12-23

US ENDOSCOPY CYTOLOGY BRUSH

Applicant United States Endoscopy Group, Inc.

K number K103437

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FDX 2005-10-11

COOK IRELAND ECHOBRUSH

Applicant Cook Ireland, Ltd.

K number K052279

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FDX 2004-05-20

WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH

Applicant Wilson-Cook Medical, Inc.

K number K040324

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FDX 2002-07-12

HORIZONS CYTOLOGY BRUSH

Applicant Horizons Intl. Corp.

K number K021998

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FDX 1997-01-08

CELL RECOVERY SYSTEM

Applicant Medical Device Technologies, Inc.

K number K965037

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FDX 1996-03-20

CELL RECOVERY SYSTEM

Applicant Medical Device Technologies, Inc.

K number K960004

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FDX 1995-10-07

CYTOLOGY BRUSH

Applicant Lighthouse Medical, Inc.

K number K954121

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FDX 1995-04-05

MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM

Applicant Biosearch Medical Products, Inc.

K number K944614

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FDX 1994-06-27

URETHRA-BRUSH

Applicant Rovers Diagnostic Devices

K number K942144

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FDX 1993-09-03

COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM

Applicant Boston Scientific Corp

K number K930348

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FDX 1992-12-07

AMCATH DISPOSABLE CYTOLOGY BRUSH

Applicant Intl. Medical, Inc.

K number K923200

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FDX 1992-11-24

CYTOLOGY BRUSH

Applicant United States Endoscopy Group, Inc.

K number K924104

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FDX 1992-08-25

CYTOLOGY BRUSH

Applicant Annex Medical, Inc.

K number K922851

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FDX 1992-02-18

CYTOLOGY BRUSH

Applicant Surgitek Medical Engineering Corp.

K number K914504

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FDX 1991-10-25

COX DISPOSABLE CYTOLOGY BRUSHES

Applicant Cox Medical Ent., Inc.

K number K914466

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FDX 1991-09-30

CYTOLOGY BRUSH

Applicant Annex Medical, Inc.

K number K913248

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FDX 1991-09-10

COX DISPOSABLE CYTOLOGY BRUSHES

Applicant Cox Medical Ent., Inc.

K number K912407

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FDX 1991-04-22

LAPAROSCOPIC CLEANING BRUSH INSTRUMENT

Applicant United States Endoscopy Group, Inc.

K number K911481

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FDX 1990-08-24

BC BRUSHES

Applicant Olympus Corp.

K number K902737

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FDX 1990-07-16

GASTROINTESTINAL CYTOLOGY BRUSH

Applicant Telemed Systems, Inc.

K number K901435

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FDX 1990-06-18

BRONCHIAL CYTOLOGY BRUSH

Applicant Telemed Systems, Inc.

K number K901436

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FDX 1990-04-09

WILSON-COOK CYTOLOGY BRUSHES

Applicant Wilson-Cook Medical, Inc.

K number K896318

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FDX 1990-01-29

PORGES CYTOLOGY BRUSHES

Applicant Porges Corp.

K number K896425

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FDX 1989-12-21

WILTEK CYTOLOGY BRUSH

Applicant Wiltek Medical, Inc.

K number K894863

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FDX 1989-08-28

HOBBS MEDICAL MICROBIOLOGY BRUSH

Applicant Hobbs Medical, Inc.

K number K893729

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FDX 1988-03-02

BERGER PROSTATE CULTURE CYTOLOGY BRUSH

Applicant Van-Tec, Inc.

K number K880095

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FDX 1986-05-02

GASTROINTESTINAL CYTOLOGY BRUSH

Applicant Endovations

K number K860997

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FDX 1985-10-04

ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH

Applicant E-Z-Em, Inc.

K number K853530

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FDX 1985-01-08

BARD URETEROSCOPIC CYTOLOGY BRUSH

Applicant C.R. Bard, Inc.

K number K844561

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FDX 1984-02-04

GASTROINTESTINAL SHEATH BRUSH

Applicant Hobbs Medical, Inc.

K number K834402

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FDX 1983-11-14

MUTO BRUSH

Applicant Microvasive

K number K833330

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FDX 1980-05-08

M.R. ASSOC. CYTOLOGY BRUSHES

Applicant Mr Associates, Inc.

K number K800966

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FDX 1979-10-01

ENDOSCOPIC CYTOLOGY BRUSHES

Applicant Mill-Rose Laboratory

K number K791668

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FDX 1977-06-01

UROLOGICAL BIOPSY BRUSH SET

Applicant Cook, Inc.

K number K770913

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