FDA Product Code FDX: Endoscopic Cytology Brush
To Collect Cells For Cytological Evaluation.
Leading manufacturers include Olympus Medical Systems Corporation.
FDA 510(k) Cleared Endoscopic Cytology Brush Devices (Product Code FDX)
About Product Code FDX - Regulatory Context
510(k) Submission Activity
44 total 510(k) submissions under product code FDX since 1977, with 44 receiving FDA clearance (average review time: 93 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under FDX have taken an average of 262 days to reach a decision - up from 89 days historically. Manufacturers should account for longer review timelines in current project planning.
FDX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →