FDA Product Code NDS: Media, Culture, Ex Vivo, Tissue And Cell
Leading manufacturers include Energy Delivery Solutions, Fujifilm Irvine Scientific and Yocon Biology Technology Company.
FDA 510(k) Cleared Media, Culture, Ex Vivo, Tissue And Cell Devices (Product Code NDS)
About Product Code NDS - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code NDS since 2001, with 8 receiving FDA clearance (average review time: 195 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NDS have taken an average of 273 days to reach a decision - up from 172 days historically. Manufacturers should account for longer review timelines in current project planning.
NDS devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →