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., Connexicon Medical , Ltd. and Chemence Medical, Inc..

9
Total
8
Cleared
203d
Avg days
2010
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Cutaneous Tissue Adhesive With Mesh Devices (Product Code OMD)

9 devices
1–9 of 9
Cleared Jul 15, 2024
CM00622 LINC Skin Closure System (CM00622 LINC)
K233460
Connexicon Medical , Ltd.
General & Plastic Surgery · 266d
Cleared May 23, 2022
LiquiBand XL
K211878
Advanced Medical Solutions Limited
General & Plastic Surgery · 336d
Cleared Dec 07, 2021
DERMABOND PRINEO Skin Closure System
K213512
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jun 05, 2020
Exofin Fusion Skin Closure System
K191461
Chemence Medical, Inc.
General & Plastic Surgery · 368d
Cleared Nov 25, 2015
DERMABOND PRINEO Skin Closure System
K152490
Ethicon, Inc.
General & Plastic Surgery · 85d
Cleared Mar 10, 2014
DERMABOND PRINEO SKIN CLOSURE SYSTEM
K133864
Ethicon, Inc.
General & Plastic Surgery · 81d

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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.