FDA Product Code OXH: Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.
Leading manufacturers include Kerecis Limited.
FDA 510(k) Cleared Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery Devices (Product Code OXH)
About Product Code OXH - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code OXH since 2015, with 5 receiving FDA clearance (average review time: 103 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OXH have taken an average of 29 days to reach a decision - down from 122 days historically, suggesting improved FDA processing for this classification.
OXH devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →