FDA Product Code NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule
Leading manufacturers include Given Imaging Ltd. (Medtronic), CapsoVision, Inc. and Ankon Technologies Co., Ltd..
FDA 510(k) Cleared System, Imaging, Gastrointestinal, Wireless, Capsule Devices (Product Code NEZ)
About Product Code NEZ - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code NEZ since 2001, with 45 receiving FDA clearance (average review time: 146 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under NEZ have taken an average of 113 days to reach a decision - down from 148 days historically, suggesting improved FDA processing for this classification.
NEZ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →