OMD · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4011
Classification
FDA Product Code
OMD
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4011
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.