Product code FDX
- Device name
- Endoscopic Cytology Brush
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- To collect cells for cytological evaluation.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | 2025-12-18 |
| K220063 | Single Use Cytology Brush | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-07-28 |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Wilson-Cook Medical, Inc. | 2019-11-14 |
| K191485 | Deflectable Brush Biopsy Set | Cook Incorporated | 2019-06-26 |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy Set | Cook Incorporated | 2019-05-01 |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2019-02-08 |
| K172663 | Cytology Brush | Micro-Tech (Nanjing) Co., Ltd. | 2018-03-05 |
| K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2017-12-29 |
| K171607 | Bronchi and Gastrointestinal Cytology Brush | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-07-31 |
| K151889 | Infinity ERCP Sampling Device | United States Endoscopy Group, Inc. | 2015-07-30 |
| K103437 | US ENDOSCOPY CYTOLOGY BRUSH | United States Endoscopy Group, Inc. | 2010-12-23 |
| K052279 | COOK IRELAND ECHOBRUSH | Cook Ireland, Ltd. | 2005-10-11 |
| K040324 | WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH | Wilson-Cook Medical, Inc. | 2004-05-20 |
| K021998 | HORIZONS CYTOLOGY BRUSH | Horizons Intl. Corp. | 2002-07-12 |
| K965037 | CELL RECOVERY SYSTEM | Medical Device Technologies, Inc. | 1997-01-08 |
| K960004 | CELL RECOVERY SYSTEM | Medical Device Technologies, Inc. | 1996-03-20 |
| K954121 | CYTOLOGY BRUSH | Lighthouse Medical, Inc. | 1995-10-07 |
| K944614 | MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM | Biosearch Medical Products, Inc. | 1995-04-05 |
| K942144 | URETHRA-BRUSH | Rovers Diagnostic Devices | 1994-06-27 |
| K930348 | COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM | Boston Scientific Corp | 1993-09-03 |
| K923200 | AMCATH DISPOSABLE CYTOLOGY BRUSH | Intl. Medical, Inc. | 1992-12-07 |
| K924104 | CYTOLOGY BRUSH | United States Endoscopy Group, Inc. | 1992-11-24 |
| K922851 | CYTOLOGY BRUSH | Annex Medical, Inc. | 1992-08-25 |
| K914504 | CYTOLOGY BRUSH | Surgitek Medical Engineering Corp. | 1992-02-18 |
| K914466 | COX DISPOSABLE CYTOLOGY BRUSHES | Cox Medical Ent., Inc. | 1991-10-25 |
| K913248 | CYTOLOGY BRUSH | Annex Medical, Inc. | 1991-09-30 |
| K912407 | COX DISPOSABLE CYTOLOGY BRUSHES | Cox Medical Ent., Inc. | 1991-09-10 |
| K911481 | LAPAROSCOPIC CLEANING BRUSH INSTRUMENT | United States Endoscopy Group, Inc. | 1991-04-22 |
| K902737 | BC BRUSHES | Olympus Corp. | 1990-08-24 |
| K901435 | GASTROINTESTINAL CYTOLOGY BRUSH | Telemed Systems, Inc. | 1990-07-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884521843219 | superDimension | Covidien LP | 2023-07-22 |
| 10884521843172 | superDimension | Covidien LP | 2023-07-21 |
| 10653405052302 | CONMED | Conmed Corporation | 2021-08-20 |
| 10653405052319 | CONMED | Conmed Corporation | 2021-08-20 |
| 30653405052252 | CONMED | Conmed Corporation | 2020-11-30 |
| 30653405052399 | CONMED | Conmed Corporation | 2020-11-26 |
| 20845854082123 | CONMED | Conmed Corporation | 2020-11-07 |
| 10653405052401 | CONMED | Conmed Corporation | 2016-09-24 |
| 10884521200531 | superDimension | Covidien LP | 2016-09-24 |
| 10884521200463 | superDimension | Covidien LP | 2016-09-24 |
| 08714729268628 | RX Cytology Brush | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10653405052388 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405052371 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405052364 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405052333 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405052289 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405052241 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653404042319 | NA | Conmed Corporation | 2016-09-24 |
| 10653404042302 | NA | Conmed Corporation | 2016-09-24 |
| M84943520 | Hobbs Microbiology Brush | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84943200 | Hobbs Microbiology Brush | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84943100 | Hobbs Microbiology Brush | HOBBS MEDICAL, INC. | 2016-09-21 |
| 10680651926606 | Halyard | Avanos Medical, Inc. | 2016-07-20 |
| 10680651926590 | Halyard | Avanos Medical, Inc. | 2016-07-20 |
| 10680651926583 | Halyard | Avanos Medical, Inc. | 2016-07-20 |
| 10680651926576 | Halyard | Avanos Medical, Inc. | 2016-07-20 |
| 10680651926569 | Halyard | Avanos Medical, Inc. | 2016-07-20 |
| 10680651926552 | Halyard | Avanos Medical, Inc. | 2016-07-20 |
| 10680651926545 | Halyard | Avanos Medical, Inc. | 2016-07-20 |
| 10680651926538 | Halyard | Avanos Medical, Inc. | 2016-07-20 |