510(k) K181317
K181317 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush". The FDA issued a decision of Substantially Equivalent on February 8, 2019. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2019
- Date Received
- May 18, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Cytology Brush
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To collect cells for cytological evaluation.