FDA Product Code OWT: Mesh, Surgical, Absorbable, Abdominal Hernia
For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair.
Leading manufacturers include Sofradim Production and Davol, Inc., A Subsidiary of C.R. Bard, Inc..
FDA 510(k) Cleared Mesh, Surgical, Absorbable, Abdominal Hernia Devices (Product Code OWT)
About Product Code OWT - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code OWT since 2003, with 11 receiving FDA clearance (average review time: 155 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 OWT have taken an average of 132 days to reach a decision - down from 157 days historically, suggesting improved FDA processing for this classification.
OWT devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →