FDA Product Code DRC: Trocar
Leading manufacturers include Synaptic Medical Corporation and Pressure Products Medical Device Manufacturing, LLC.
FDA 510(k) Cleared Trocar Devices (Product Code DRC)
About Product Code DRC - Regulatory Context
510(k) Submission Activity
51 total 510(k) submissions under product code DRC since 1977, with 51 receiving FDA clearance (average review time: 123 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 DRC have taken an average of 104 days to reach a decision - down from 123 days historically, suggesting improved FDA processing for this classification.
DRC devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →