FDX — Endoscopic Cytology Brush Class II
FDA product code FDX covers "Endoscopic Cytology Brush", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FDX
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To collect cells for cytological evaluation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250993 | olympus medical systems corporation | Single Use Cytology Brush V (BC-V600P-3010) | December 18, 2025 |
| K220063 | zhejiang chuangxiang medical technology co | Single Use Cytology Brush | July 28, 2022 |
| K192908 | wilson-cook medical | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | November 14, 2019 |
| K191485 | cook incorporated | Deflectable Brush Biopsy Set | June 26, 2019 |
| K182231 | cook incorporated | Brush Biopsy Set ; Deflectable Brush Biopsy Set | May 1, 2019 |
| K181317 | wilson-cook medical | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | February 8, 2019 |
| K172663 | micro-tech (nanjing) co | Cytology Brush | March 5, 2018 |
| K171573 | wilson-cook medical | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | December 29, 2017 |
| K171607 | wilson-cook medical inc./cook endoscopy | Bronchi and Gastrointestinal Cytology Brush | July 31, 2017 |
| K151889 | united states endoscopy group | Infinity ERCP Sampling Device | July 30, 2015 |
| K103437 | united states endoscopy group | US ENDOSCOPY CYTOLOGY BRUSH | December 23, 2010 |
| K052279 | cook ireland | COOK IRELAND ECHOBRUSH | October 11, 2005 |
| K040324 | wilson-cook medical | WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH | May 20, 2004 |
| K021998 | horizons intl | HORIZONS CYTOLOGY BRUSH | July 12, 2002 |
| K965037 | medical device technologies | CELL RECOVERY SYSTEM | January 8, 1997 |
| K960004 | medical device technologies | CELL RECOVERY SYSTEM | March 20, 1996 |
| K954121 | lighthouse medical | CYTOLOGY BRUSH | October 7, 1995 |
| K944614 | biosearch medical products | MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM | April 5, 1995 |
| K942144 | rovers diagnostic devices | URETHRA-BRUSH | June 27, 1994 |
| K930348 | boston scientific | COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM | September 3, 1993 |