DeviceClearance

Product code NEZ— Gastroenterology, Urology

GIVEN DIAGNOSTIC SYSTEM

Classification name
System, Imaging, Gastrointestinal, Wireless, Capsule
Device class
Class 2
Regulation
21 CFR 876.1300
Advisory panel
Gastroenterology, Urology
Total cleared
47
First cleared
Most recent

Market context for product code NEZ

FDA has cleared 47 devices under product code NEZ between 2001 and 2026, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NEZ

Adverse events under product code NEZ

product code NEZ
Death
11
Injury
218
Total
229

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NEZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.