# K191461: Exofin Fusion Skin Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Chemence Medical, Inc.
- Decided: Jun 5, 2020 after 368 days
- Product code: OMD (Cutaneous Tissue Adhesive With Mesh)
- Device class: 2
- Regulation: 21 CFR 878.4011
- 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 DEN090005 (2010). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171442: Exofin Fusion Skin Closure System, Chemence Medical, Inc. (2017) Summary page 5.

## Most influential descendants
- K211878: LiquiBand XL (2022), 0 descendants of its own

## Indications for use
Exofin Fusion Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin Fusion Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

Source page: https://510kreport.com/device/K191461
Methodology: https://510kreport.com/methodology