510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191485Substantially Equivalent

Deflectable Brush Biopsy Set

Cook Incorporated, Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191485 is the FDA 510(k) clearance record for Deflectable Brush Biopsy Set, a class II device, cleared for Cook Incorporated 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 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K191485.

Clearance record

Decision date
Received
(22 days to decision)
Product code
FDX Endoscopic Cytology Brush
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Incorporated 750 Daniels Way, Bloomington IN
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