FDA Product Code NYV: Gastrointestinal Motility System, Capsule
Used To Evaluate Gi Motility Disorders And Indicated For Use In Evaluating Patients With Suspected Motility Disorders.
Leading manufacturers include Anx Robotica Corporation and Atmo Biosciences, Ltd..
FDA 510(k) Cleared Gastrointestinal Motility System, Capsule Devices (Product Code NYV)
About Product Code NYV - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code NYV since 2006, with 4 receiving FDA clearance (average review time: 119 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NYV have taken an average of 90 days to reach a decision - down from 149 days historically, suggesting improved FDA processing for this classification.
NYV devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →