FDA Product Code OAB: Low Energy Direct Current Thermal Ablation System
Ablation Of Soft Tissue
Leading manufacturers include Galvanize Therapeutics, Inc., Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. and AngioDynamics, Inc..
FDA 510(k) Cleared Low Energy Direct Current Thermal Ablation System Devices (Product Code OAB)
About Product Code OAB - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code OAB since 2006, with 13 receiving FDA clearance (average review time: 203 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under OAB have taken an average of 170 days to reach a decision - down from 213 days historically, suggesting improved FDA processing for this classification.
OAB devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →