OMD

Cutaneous Tissue Adhesive With Mesh

Product code

OMD

Device name

Cutaneous Tissue Adhesive With Mesh

Device class

Class 2

21 CFR

21 CFR 878.4011

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

9

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-07-15.

1 summaries are archived here for direct download.