# K152490: DERMABOND PRINEO Skin Closure System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Nov 25, 2015 after 85 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: 2 generations back to DEN090005 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN090005: Prineo Skin Closure System, Closure Medical Corp. (2010). Our OCR of the scanned summary read K082289, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090005, Prineo Skin Closure System (Closure Medical Corp.), granted Apr 30, 2010; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.
- DEN090005: Prineo Skin Closure System, Closure Medical Corp. (2010) Summary page 4.
- K133864: Dermabond Prineo Skin Closure System, ETHICON, Inc. (2014) Summary page 4.

## Indications for use
DERMABOND™ PRINEO™ System 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. DERMABOND™ PRINEO™ 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/K152490
Methodology: https://510kreport.com/methodology