510(k) K161011
K161011 is an FDA 510(k) premarket notification submitted by Adhezion Biomedical, LLC for the device "SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive". The FDA issued a decision of Substantially Equivalent on November 8, 2016. The device falls under product code MPN (Tissue Adhesive For The Topical Approximation Of Skin), a Class II device regulated under 21 CFR 878.4010. Adhezion Biomedical, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2016
- Date Received
- April 11, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Adhesive For The Topical Approximation Of Skin
- Device Class
- Class II
- Regulation Number
- 878.4010
- Review Panel
- SU
- Submission Type
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).