K163645 is an FDA 510(k) clearance for the DERMABOND PRINEO Skin Closure System, a Cutaneous Tissue Adhesive With Mesh (Class II — Special Controls, product code OMD), submitted by Ethicon, LLC (Somerville, US). The FDA issued a Cleared decision on April 21, 2017, 119 days after receiving the submission on December 23, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4011.
| 510(k) Number | K163645 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 2016 |
| Decision Date | April 21, 2017 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OMD — Cutaneous Tissue Adhesive With Mesh |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4011 |
| 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. |