# K100423: Dermabond NX Adhesive Model: DNX6, DNX12

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: May 4, 2010 after 77 days
- Product code: MPN (Tissue Adhesive For The Topical Approximation Of Skin)
- Device class: 2
- Regulation: 21 CFR 878.4010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P960052 (1998). 1 ancestor in all.
20 later devices descend from it; 8 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960052: Dermabond (a Formulation of 2-Octyl Cyanoacrylate), Closure Medical Corp. (1998) Summary page 1.

## Most influential descendants
- K130329: Surgiseal Topical Skin Adhesive (2013), 3 descendants of its own
- K130474: Surgiseal Topical Skin Adhesive (2013), 3 descendants of its own
- K123133: Barle Tissue Adhesive (2013), 3 descendants of its own
- K152476: Exofin High Viscosity Tissue Adhesive (2016), 2 descendants of its own
- K152096: DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive (2015), 2 descendants of its own

## Recalls of this device
- Jan 4, 2021 · Class II · Z-0953-2021: Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

## Indications for use
DERMABOND NX 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. DERMABOND NX Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Source page: https://510kreport.com/device/K100423
Methodology: https://510kreport.com/methodology