K213512 is an FDA 510(k) clearance for the DERMABOND PRINEO Skin Closure System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4011. 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..
| 510(k) Number | K213512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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. |