# K152096: DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Oct 22, 2015 after 86 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: 2 generations back to P960052 (1998). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K100423: Dermabond NX Adhesive Model: DNX6, DNX12, ETHICON, Inc. (2010) Summary page 5.
- P960052: Dermabond (a Formulation of 2-Octyl Cyanoacrylate), Closure Medical Corp. (1998) Summary page 5.

## Most influential descendants
- K243990: BondEase 2 Topical Skin Adhesive (2025), 0 descendants of its own
- K233458: CM005 Standard (CM005); CM004 Mini (CM004) (2024), 0 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 ADVANCED™ 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 ADVANCED™ Adhesive may be used in conjunction with, but not in place of, deep dermal stitches. High viscosity DERMABOND® Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. High viscosity DERMABOND® Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Source page: https://510kreport.com/device/K152096
Methodology: https://510kreport.com/methodology