Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
FDA 510(k) clearance K181317 · decided 2019-02-08
Clearance details
- K-number
- K181317
- Device name
- Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-18
- Decision date
- 2019-02-08
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- FDX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.