Cleared Special

K213512 - DERMABOND PRINEO Skin Closure System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213512 · Ethicon, Inc. · General & Plastic Surgery device
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Dec 2021
Decision
35d
Days
Class 2
Risk

K213512 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, Inc. (Raritan, US). The FDA issued a Cleared decision on December 7, 2021 after a review of 35 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K213512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2021
Decision Date December 07, 2021
Days to Decision 35 days
Submission Type Special
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
79d faster than avg
Panel avg: 114d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.