FDA Product Code KGC: Tube, Gastro-enterostomy
Leading manufacturers include Coaptech, Inc..
FDA 510(k) Cleared Tube, Gastro-enterostomy Devices (Product Code KGC)
About Product Code KGC - Regulatory Context
510(k) Submission Activity
26 total 510(k) submissions under product code KGC since 1978, with 26 receiving FDA clearance (average review time: 114 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 KGC have taken an average of 274 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.
KGC devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →