# K152476: Exofin High Viscosity Tissue Adhesive

- Pathway: 510(k) (Abbreviated)
- Applicant: Chemence Medical Products, Inc.
- Decided: Feb 9, 2016 after 162 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: 2 generations back to P960052 (1998). 3 ancestors in all.
2 later devices descend 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)
- K101276: Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404, Chemence Medical Products, Inc. (2010) Summary page 4.
- K100423: Dermabond NX Adhesive Model: DNX6, DNX12, ETHICON, Inc. (2010) Summary page 4.

## Most influential descendants
- K200264: Exofin High Viscosity Topical Skin Adhesive (2020), 1 descendant of its own
- K212246: Exofin Precision Pen (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K152476
Methodology: https://510kreport.com/methodology