Cleared Traditional

K163645 - DERMABOND PRINEO Skin Closure System

K163645 is an FDA 510(k) clearance for DERMABOND PRINEO Skin Closure System, manufactured by Ethicon, LLC. The device is a Class 2 General & Plastic Surgery device with product code OMD cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K163645 · Ethicon, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
119d
Days
Class 2
Risk

K163645 is an FDA 510(k) clearance for the DERMABOND PRINEO Skin Closure System. Classified as Cutaneous Tissue Adhesive With Mesh (product code OMD), Class II - Special Controls.

Submitted by Ethicon, LLC (Somerville, US). The FDA issued a Cleared decision on April 21, 2017 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4011 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K163645

510(k) Number K163645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date April 21, 2017
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMD Device Classification - Class 2, Special Controls

Product Code OMD Cutaneous Tissue Adhesive With Mesh
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4011
Definition For Topical Application Only To Hold Closed Easily Approximated Skin Edges Of Wounds Such As Wounds From Surgical Incisions, Including Punctures From Minimally Invasive Surgery, And Simple Thorough Cleansed, Trauma-induced Lacerations. The Device May Be Used In Conjunction With, But Not In Place Of, Deep Dermal Sutures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OMD Cutaneous Tissue Adhesive With Mesh

All 8
Devices cleared under the same product code (OMD) and FDA review panel - the closest regulatory comparables to K163645.
DERMABOND PRINEO Skin Closure System
K213512 · Ethicon, Inc. · Dec 2021
Exofin Fusion Skin Closure System
K191461 · Chemence Medical, Inc. · Jun 2020
Exofin Fusion Skin Closure System
K171442 · Chemence Medical, Inc. · Sep 2017
DERMABOND PRINEO Skin Closure System
K152490 · Ethicon, Inc. · Nov 2015
DERMABOND PRINEO SKIN CLOSURE SYSTEM
K133864 · Ethicon, Inc. · Mar 2014
PRINEO SKIN CLOSURE SYSTEM
DEN090005 · Closure Medical Corp. · Apr 2010
K163645 · DERMABOND PRINEO Skin Closure System
Download PDF FDA Summary Ethicon, LLC