FDXClass II

Endoscopic Cytology Brush

21 CFR 876.1500 / Gastroenterology, Urology

FDX is the FDA product code for Endoscopic Cytology Brush, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To collect cells for cytological evaluation". As of 2026-09-10, FDA records hold 44 510(k) clearances under this code, the most recent dated 2025-12-18, and 5 recalls.

Classification record

Product code: FDX
Device name: Endoscopic Cytology Brush
FDA definition: To collect cells for cytological evaluation.
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 44
Ingested recalls: 5

Clearances, product code FDX

By decision year

44 clearances under product code FDX with a decision year between 1977 and 2025, 1990 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code FDX by decision year
Year	Clearances
1977	1
1979	1
1980	1
1983	1
1984	1
1985	2
1986	1
1988	1
1989	2
1990	5
1991	4
1992	4
1993	1
1994	1
1995	2
1996	1
1997	1
2002	1
2004	1
2005	1
2010	1
2015	1
2017	2
2018	1
2019	4
2022	1
2025	1

Applicants with the most clearances

Product code FDX

Applicants holding the most 510(k) clearances under product code FDX
Applicant	Clearances
Wilson-Cook Medical Inc.	5
United States Endoscopy Group, Inc.	4
Annex Medical, Inc.	2
Cook Incorporated	2
Cox Medical Ent., Inc.	2
Hobbs Medical, Inc.	2
Medical Device Technologies, Inc.	2
TeleMed Systems	2
Biosearch Medical Products, Inc.	1
Boston Scientific Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order