# K133963: Surgiseal Twist (TM) Topical Skin Adhesive

- Pathway: 510(k) (Special)
- Applicant: Adhezion Biomedical, LLC
- Decided: Sep 9, 2014 after 259 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: 3 generations back to P960052 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130474: Surgiseal Topical Skin Adhesive, Adhezion Biomedical, LLC (2013) Summary page 4.

## 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/K133963
Methodology: https://510kreport.com/methodology