# K200264: Exofin High Viscosity Topical Skin Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Chemence Medical, Inc.
- Decided: Dec 17, 2020 after 318 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152476: Exofin High Viscosity Tissue Adhesive, Chemence Medical Products, Inc. (2016) Summary page 4.

## Most influential descendants
- K212246: Exofin Precision Pen (2021), 0 descendants of its own

## Indications for use
Exofin® High Viscosity Topical Skin Adhesive 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® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

Source page: https://510kreport.com/device/K200264
Methodology: https://510kreport.com/methodology