510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181317Substantially Equivalent

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

Wilson-Cook Medical Inc., Winston-Salem NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181317 is the FDA 510(k) clearance record for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush, a class II device, cleared for Wilson-Cook Medical, Inc. on under FDA product code FDX (Endoscopic Cytology Brush). FDA's definition for product code FDX reads: "To collect cells for cytological evaluation". FDA records list 131 510(k) clearances for Wilson-Cook Medical, Inc., from to . As of , FDA records show no recalls naming K181317.

Clearance record

Decision date
Received
(266 days to decision)
Product code
FDX Endoscopic Cytology Brush
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Wilson-Cook Medical, Inc. 4900 Bethania Station Rd., Winston-Salem NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDX

Trailing 12 months
1 clearance under product code FDX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FDX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260