FDA Product Code MPN: Tissue Adhesive For The Topical Approximation Of Skin
Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k).
Leading manufacturers include Okapi Medical, LLC Dba Resivant Medical, Optmed, Inc. and Chemence Medical, Inc..
FDA 510(k) Cleared Tissue Adhesive For The Topical Approximation Of Skin Devices (Product Code MPN)
About Product Code MPN - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code MPN since 2008, with 36 receiving FDA clearance (average review time: 194 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MPN have taken an average of 225 days to reach a decision - up from 190 days historically. Manufacturers should account for longer review timelines in current project planning.
MPN devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →