SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive— 510(k) K161011
Substantially EquivalentAdhezion Biomedical, LLC
FDA 510(k) clearance K161011 for SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive, Substantially Equivalent on 2016-11-08. Applicant: Adhezion Biomedical, LLC.
Clearance details
- Applicant
- Adhezion Biomedical, LLC
- Product code
- Code MPN
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wyomissing, PA, US
Adverse events under product code MPN
product code MPN- Injury
- 856
- Other
- 1
- Total
- 857
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.