FDA Product Code OXC: Mesh, Surgical, Absorbable, Staple Line Reinforcement
For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.
Leading manufacturers include Ethicon Endo-Surgery, LLC.
FDA 510(k) Cleared Mesh, Surgical, Absorbable, Staple Line Reinforcement Devices (Product Code OXC)
About Product Code OXC - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code OXC since 2013, with 9 receiving FDA clearance (average review time: 114 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
FDA review times for OXC submissions have been consistent, averaging 119 days recently vs 113 days historically.
OXC devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →