# K213512: DERMABOND PRINEO Skin Closure System

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Dec 7, 2021 after 35 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)
- 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/K213512
Methodology: https://510kreport.com/methodology