SURGISEAL TOPICAL SKIN ADHESIVE— 510(k) K130474
Substantially EquivalentAdhezion Biomedical, LLC
FDA 510(k) clearance K130474 for SURGISEAL TOPICAL SKIN ADHESIVE, Substantially Equivalent on 2013-05-31. 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
- Abbreviated
- 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 all- K223669 — SecurePortIV Advanced Catheter Securement Adhesive
- K170505 — SecurePortIV Catheter Securement Adhesive
- K161011 — SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
- K150866 — SURGISEAL Topical Skin Adhesvie
- K133963 — SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
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.