K161011 is an FDA 510(k) clearance for the SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive. This device is classified as a Tissue Adhesive For The Topical Approximation Of Skin (Class II - Special Controls, product code MPN).
Submitted by Adhezion Biomedical, LLC (Wyomissing, US). The FDA issued a Cleared decision on November 8, 2016, 211 days after receiving the submission on April 11, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4010. Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k)..
| 510(k) Number | K161011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2016 |
| Decision Date | November 08, 2016 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MPN - Tissue Adhesive For The Topical Approximation Of Skin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4010 |
| Definition | Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k). |