# K140517: Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Adhezion Biomedical, LLC
- Decided: Apr 28, 2014 after 59 days
- Product code: MPN (Tissue Adhesive For The Topical Approximation Of Skin)
- Device class: 2
- Regulation: 21 CFR 878.4010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to P010002 (2002). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082993: Surgiseal Topical Skin Adhesive, Adhezion Biomedical (2008) Summary page 1.
- K123936: Surgiseal Topical Skin Adhesive, Adhezion Biomedical, LLC (2013) Summary page 1.
- K130329: Surgiseal Topical Skin Adhesive, Adhezion Biomedical, LLC (2013) Summary page 1.
- K130474: Surgiseal Topical Skin Adhesive, Adhezion Biomedical, LLC (2013) Summary page 1.
- P960052: Dermabond (a Formulation of 2-Octyl Cyanoacrylate), Closure Medical Corp. (1998) Summary page 1.
- P010002: Indermil (TM) Tissue Adhesive, Covidien Lp, Formerly Registered AS United States (2002) Summary page 1.
- K122446: Liquidband Flow Control, Advanced Medical Solutions (Plymouth), Ltd. (2012) Summary page 1.

## Most influential descendants
- K141215: Surgiseal Twist Topical Skin Adhesive (2014), 0 descendants of its own

## Indications for use
SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures

Source page: https://510kreport.com/device/K140517
Methodology: https://510kreport.com/methodology