FETClass II

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

21 CFR 876.1500 / Gastroenterology, Urology

FET is the FDA product code for Endoscopic Video Imaging System/Component, Gastroenterology-Urology, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To allow for visualization of body cavities through an endoscope by projecting images to a monitor". As of 2026-09-10, FDA records hold 100 510(k) clearances under this code, the most recent dated 2026-07-02, and 8 recalls.

Classification record

Product code: FET
Device name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
FDA definition: To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
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: No
Ingested clearances: 101
Ingested recalls: 8

Clearances, product code FET

By decision year

101 clearances under product code FET with a decision year between 1981 and 2026, 1994 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code FET by decision year
Year	Clearances
1981	1
1982	2
1983	2
1984	1
1986	1
1987	1
1990	4
1991	3
1992	1
1993	1
1994	7
1995	7
1996	3
1997	5
1998	2
1999	2
2000	2
2001	5
2002	1
2003	4
2004	1
2005	1
2007	1
2008	2
2009	2
2010	1
2011	2
2012	2
2013	2
2015	2
2016	1
2017	3
2018	3
2019	3
2020	5
2021	1
2022	2
2023	1
2024	2
2025	6
2026	3

Applicants with the most clearances

Product code FET

Applicants holding the most 510(k) clearances under product code FET
Applicant	Clearances
Karl Storz Endoscopy-America, Inc.	14
Olympus Medical Systems Corp.	9
Richard Wolf Medical Instruments Corp.	8
FUJIFILM Healthcare Americas Corporation	5
Karl Storz Imaging, Inc.	5
FUJIFILM Corporation	3
OLYMPUS Corporation of the Americas	3
Precise Optics	3
Marks & Murase	2
Medical Laser, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 79 companies shown, in name order