OMD — Cutaneous Tissue Adhesive With Mesh Class II
FDA product code OMD covers "Cutaneous Tissue Adhesive With Mesh", a Class II medical device regulated under 21 CFR 878.4011. Submissions are reviewed by the General, Plastic Surgery panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OMD
- Device Class
- Class II
- Regulation Number
- 878.4011
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233460 | connexicon medical | CM00622 LINC Skin Closure System (CM00622 LINC) | July 15, 2024 |
| K211878 | advanced medical solutions limited | LiquiBand XL | May 23, 2022 |
| K213512 | ethicon | DERMABOND PRINEO Skin Closure System | December 7, 2021 |
| K191461 | chemence medical | Exofin Fusion Skin Closure System | June 5, 2020 |
| K171442 | chemence medical | Exofin Fusion Skin Closure System | September 25, 2017 |
| K163645 | ethicon | DERMABOND PRINEO Skin Closure System | April 21, 2017 |
| K152490 | ethicon | DERMABOND PRINEO Skin Closure System | November 25, 2015 |
| K133864 | ethicon | DERMABOND PRINEO SKIN CLOSURE SYSTEM | March 10, 2014 |
| DEN090005 | closure medical | PRINEO SKIN CLOSURE SYSTEM | April 30, 2010 |