FDA Product Code NDS: Media, Culture, Ex Vivo, Tissue And Cell
Leading manufacturers include Duogenic Stemcells Corporation, Energy Delivery Solutions and Fujifilm Irvine Scientific.
9
Total
8
Cleared
195d
Avg days
2001
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
381d
recently vs 171d historically
FDA 510(k) Cleared Media, Culture, Ex Vivo, Tissue And Cell Devices (Product Code NDS)
9 devices
Cleared
Sep 06, 2024
MSC SFM
Yocon Biology Technology Company
Gastroenterology & Urology
381d
Cleared
Jul 12, 2024
“MoFi” Cell Culture Basal Medium
Duogenic Stemcells Corporation
Gastroenterology & Urology
164d
Cleared
Nov 09, 2023
PRIME-XV FreezIS DMSO-Free MD
Fujifilm Irvine Scientific
Gastroenterology & Urology
142d
Cleared
Sep 20, 2021
CT-STOR
Energy Delivery Solutions
Gastroenterology & Urology
447d
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 declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - NDS Product Code
Recent submissions under NDS have taken an average of 381 days to reach a decision - up from 171 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 →