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. Device class: 2.
Clearance details
- Applicant
- Adhezion Biomedical, LLC
- Product code
- Code MPN
- Device class
- Class 2
- Regulation
- 21 CFR 878.4010
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wyomissing, PA, US
Recent devices under product code MPN
view all- K243990 — BondEase 2 Topical Skin Adhesive
- K250950 — CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739)
- K234114 — CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)
- K233458 — CM005 Standard (CM005); CM004 Mini (CM004)
- K230981 — Meriglu Topical Skin Adhesive
More clearances from Adhezion Biomedical, LLC
view allAdverse 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.