FDA Product Code FCX: Insufflator, Automatic Carbon-dioxide For Endoscope
Leading manufacturers include Ide Vision, Ltd..
FDA 510(k) Cleared Insufflator, Automatic Carbon-dioxide For Endoscope Devices (Product Code FCX)
About Product Code FCX - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code FCX since 1985, with 24 receiving FDA clearance (average review time: 132 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 FCX have taken an average of 217 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
FCX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →