FDA 510(k) Applications for Medical Device Product Code "FDX"
(Endoscopic Cytology Brush)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K182231 | Cook Incorporated | Brush Biopsy Set ; Deflectable Brush Biopsy Set | 05/01/2019 |
| K191485 | Cook Incorporated | Deflectable Brush Biopsy Set | 06/26/2019 |
| K052279 | COOK IRELAND LTD | COOK IRELAND ECHOBRUSH | 10/11/2005 |
| K021998 | HORIZONS INTL. CORP. | HORIZONS CYTOLOGY BRUSH | 07/12/2002 |
| K965037 | MEDICAL DEVICE TECHNOLOGIES, INC. | CELL RECOVERY SYSTEM | 01/08/1997 |
| K960004 | MEDICAL DEVICE TECHNOLOGIES, INC. | CELL RECOVERY SYSTEM | 03/20/1996 |
| K172663 | Micro-Tech (Nanjing) CO., Ltd. | Cytology Brush | 03/05/2018 |
| K151889 | UNITED STATES ENDOSCOPY GROUP, INC. | Infinity ERCP Sampling Device | 07/30/2015 |
| K103437 | UNITED STATES ENDOSCOPY GROUP, INC. | US ENDOSCOPY CYTOLOGY BRUSH | 12/23/2010 |
| K192908 | Wilson-Cook Medical, Inc | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | 11/14/2019 |
| K171573 | Wilson-Cook Medical, Inc. | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | 12/29/2017 |
| K181317 | Wilson-Cook Medical, Inc. | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | 02/08/2019 |
| K040324 | WILSON-COOK MEDICAL, INC. | WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH | 05/20/2004 |
| K171607 | Wilson-Cook Medical, Inc. / Cook Endoscopy | Bronchi and Gastrointestinal Cytology Brush | 07/31/2017 |
| K220063 | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Single Use Cytology Brush | 07/28/2022 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
