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OMDClass II

Cutaneous Tissue Adhesive With Mesh

21 CFR 878.4011 / General, Plastic Surgery

OMD is the FDA product code for Cutaneous Tissue Adhesive With Mesh, a class II device type, regulated under 21 CFR 878.4011. FDA's definition for this code reads: "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". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OMD
Device name
Cutaneous Tissue Adhesive With Mesh
FDA 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.
Regulation
21 CFR 878.4011
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code OMD

By decision year
9 clearances under product code OMD with a decision year between 2010 and 2024, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OMD by decision year
YearClearances
20101
20141
20151
20172
20201
20211
20221
20241

Applicants with the most clearances

Product code OMD
Applicants holding the most 510(k) clearances under product code OMD
ApplicantClearances
Ethicon, Inc4
Chemence Medical Inc.2
Advanced Medical Solutions Limited1
Closure Medical Corp.1
Connexicon Medical, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code