Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
FDA 510(k) K171573 · Wilson-Cook Medical, Inc.
510(k) numberK171573
Submission
- Device name
- Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- May 30, 2017
- Decision date
- December 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDX – Endoscopic Cytology Brush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To collect cells for cytological evaluation.
Other 510(k)s with product code FDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250993 | Single Use Cytology Brush V (BC-V600P-3010)FDX · Traditional | Olympus Medical Systems Corporation | 12/18/2025SE |
| K220063 | Single Use Cytology BrushFDX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 07/28/2022SE |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesFDX · Special | Wilson-Cook Medical, Inc. | 11/14/2019SE |
| K191485 | Deflectable Brush Biopsy SetFDX · Traditional | Cook Incorporated | 06/26/2019SE |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy SetFDX · Traditional | Cook Incorporated | 05/01/2019SE |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushFDX · Traditional | Wilson-Cook Medical, Inc. | 02/08/2019SE |
| K172663 | Cytology BrushFDX · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 03/05/2018SE |
| K171607 | Bronchi and Gastrointestinal Cytology BrushFDX · Traditional | Wilson-Cook Medical Inc./Cook Endoscopy | 07/31/2017SE |
| K151889 | Infinity ERCP Sampling DeviceFDX · Special | United States Endoscopy Group, Inc. | 07/30/2015SE |
| K103437 | US Endoscopy Cytology BrushFDX · Special | United States Endoscopy Group, Inc. | 12/23/2010SE |
More from United States Endoscopy Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X])QAU · Traditional | 06/02/2026SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | 09/29/2025SE |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordKNS · Special | 01/17/2025SE |
| K213483 | SnapLoc Wire LockODC · Traditional | 04/26/2022SE |
| K213356 | Entuit PEG, Entuit PEGJPIF · Special | 01/20/2022SESD |
| K212323 | Instinct Plus Endoscopic Clipping DevicePKL · Special | 08/25/2021SE |
| K201322 | Entuit Nasal Jejunal Feeding TubeKNT · Special | 06/17/2020SESK |
| K200972 | Hemospray Endoscopic HemostatQAU · Traditional | 06/10/2020SE |
| K200247 | Fusion Quattro Extraction BalloonGCA · Special | 02/27/2020SE |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordKNS · Traditional | 01/30/2020SE |
Questions and answers
When was Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush cleared by the FDA?
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (K171573) received a 510(k) decision of Substantially Equivalent on December 29, 2017, 213 days after the submission was received.
What is the product code of K171573?
The FDA product code is FDX – Endoscopic Cytology Brush, a Class II (moderate risk) device regulated under 21 CFR 876.1500.