Product code OMD— General, Plastic Surgery
DERMABOND PRINEO Skin Closure System
- Classification name
- Cutaneous Tissue Adhesive With Mesh
- Device class
- Class 2
- Regulation
- 21 CFR 878.4011
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 9
- First cleared
- Most recent
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.”
Market context for product code OMD
FDA has cleared devices under product code OMD between 2010 and 2024, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2022
- 2021
- 2020
- 2017
- 2015
- 2014
- 2010
Top applicants under product code OMD
Adverse events under product code OMD
product code OMD- Injury
- 1,134
- Total
- 1,134
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OMD
- K233460 — CM00622 LINC Skin Closure System (CM00622 LINC)
- K211878 — LiquiBand XL
- K213512 — DERMABOND PRINEO Skin Closure System
- K191461 — Exofin Fusion Skin Closure System
- K171442 — Exofin Fusion Skin Closure System
- K163645 — DERMABOND PRINEO Skin Closure System
- K152490 — DERMABOND PRINEO Skin Closure System
- K133864 — DERMABOND PRINEO SKIN CLOSURE SYSTEM
- DEN090005 — PRINEO SKIN CLOSURE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.