NEZClass II

System, Imaging, Gastrointestinal, Wireless, Capsule

21 CFR 876.1300 / Gastroenterology, Urology

NEZ is the FDA product code for System, Imaging, Gastrointestinal, Wireless, Capsule, a class II device type, regulated under 21 CFR 876.1300. As of 2026-09-10, FDA records hold 47 510(k) clearances under this code, the most recent dated 2026-05-08, and 6 recalls.

Classification record

Product code: NEZ
Device name: System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation: 21 CFR 876.1300
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: 47
Ingested recalls: 6

Clearances, product code NEZ

By decision year

47 clearances under product code NEZ with a decision year between 2001 and 2026, 2017 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code NEZ by decision year
Year	Clearances
2001	1
2002	2
2003	3
2004	2
2006	2
2007	2
2009	2
2010	1
2011	3
2012	1
2013	3
2014	3
2015	2
2016	2
2017	4
2018	3
2019	2
2020	1
2021	1
2022	1
2023	1
2024	3
2025	1
2026	1

Applicants with the most clearances

Product code NEZ

Applicants holding the most 510(k) clearances under product code NEZ
Applicant	Clearances
Given Imaging Ltd.	19
IntroMedic Co., Ltd.	8
Olympus Medical Systems Corp.	7
CapsoVision, Inc.	6
Given Imaging Ltd. (Medtronic)	2
United States Endoscopy Group, Inc.	2
Ankon Technologies Co., Ltd.	1
Anx Robotica Corp.	1
Given Imaging Ltd. (D.B.A. Medtronic)	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order