OMD · Class II · 21 CFR 878.4011

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 Ethicon, Inc..

1
Total
1
Cleared
35d
Avg days
2021
Since

List of Cutaneous Tissue Adhesive With Mesh devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Dec 07, 2021
DERMABOND PRINEO Skin Closure System
K213512
Ethicon, Inc.
General & Plastic Surgery · 35d

How to use this database

This page lists all FDA 510(k) submissions for Cutaneous Tissue Adhesive With Mesh devices (product code OMD). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →