FDA Product Code OMD: Cutaneous Tissue Adhesive With Mesh
For Topical Application Only To Hold Closed Easily Approximated Skin Edges Of Wounds Such As Wounds From Surgical Incisions, Including Punctures From Minimally Invasive Surgery, And Simple Thorough Cleansed, Trauma-induced Lacerations. The Device May Be Used In Conjunction With, But Not In Place Of, Deep Dermal Sutures.
Leading manufacturers include Advanced Medical Solutions Limited, Ethicon, Inc. and Connexicon Medical , Ltd..
FDA 510(k) Cleared Cutaneous Tissue Adhesive With Mesh Devices (Product Code OMD)
About Product Code OMD - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code OMD since 2010, with 8 receiving FDA clearance (average review time: 203 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 OMD have taken an average of 266 days to reach a decision - up from 195 days historically. Manufacturers should account for longer review timelines in current project planning.
OMD devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →