Clearance Summary
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush received FDA 510(k) clearance under submission number K181317, sponsored by Wilson-Cook Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-02-08.
- Submission: K181317
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2019-02-08
Classification & Regulation
This clearance is catalogued under FDA product code FDX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.