FDX

Endoscopic Cytology Brush

Product code
FDX
Device name
Endoscopic Cytology Brush
Device class
Class 2
21 CFR
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
44 (all years; only the last 3 years are listed here)

FDA classification definition

To collect cells for cytological evaluation.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-12-18.

NumberDecision dateApplicantDevice nameSummary
K2509932025-12-18Olympus Medical Systems CorporationSingle Use Cytology Brush V (BC-V600P-3010)PDF

1 summaries are archived here for direct download.

Official FDA classification page: FDX
Classification and pathway per current FDA publications. Data from openFDA (CC0).