# K133864: Dermabond Prineo Skin Closure System

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Mar 10, 2014 after 81 days
- Product code: OMD (Cutaneous Tissue Adhesive With Mesh)
- Device class: 2
- Regulation: 21 CFR 878.4011
- 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 DEN090005 (2010). 1 ancestor in all.
9 later devices descend from it; 6 cite it directly.
0 of 11 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 reading of the summary gave 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.

## Most influential descendants
- K171442: Exofin Fusion Skin Closure System (2017), 2 descendants of its own
- K234114: CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System (RM-1739) (2024), 1 descendant of its own
- K191461: Exofin Fusion Skin Closure System (2020), 1 descendant of its own
- K250950: CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) (2025), 0 descendants of its own
- K233460: CM00622 LINC Skin Closure System (CM00622 LINC) (2024), 0 descendants of its own

## Recalls of this device
- Nov 27, 2017 · Class II · Z-1147-2018: Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.

## Indications for use
DERMABOND PRINEO Skin Closure 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 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/K133864
Methodology: https://510kreport.com/methodology