K213512 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, Inc. (Raritan, US). The FDA issued a Cleared decision on December 7, 2021, 35 days after receiving the submission on November 2, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4011.
| 510(k) Number | K213512 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 2021 |
| Decision Date | December 07, 2021 |
| Days to Decision | 35 days |
| Submission Type | Special |
| 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. |