K191461 is an FDA 510(k) clearance for the Exofin Fusion Skin Closure System. This device is classified as a Cutaneous Tissue Adhesive With Mesh (Class II - Special Controls, product code OMD).
Submitted by Chemence Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 5, 2020, 368 days after receiving the submission on June 3, 2019.
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 | K191461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2019 |
| Decision Date | June 05, 2020 |
| Days to Decision | 368 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. |