Cleared Abbreviated

K171442 - Exofin Fusion Skin Closure System (FDA 510(k) Clearance)

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

K171442 · Chemence Medical, Inc. · General & Plastic Surgery device
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Sep 2017
Decision
132d
Days
Class 2
Risk

K171442 is an FDA 510(k) clearance for the Exofin Fusion Skin Closure System. Classified as Cutaneous Tissue Adhesive With Mesh (product code OMD), Class II - Special Controls.

Submitted by Chemence Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 25, 2017 after a review of 132 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Chemence Medical, Inc. devices

Submission Details

510(k) Number K171442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2017
Decision Date September 25, 2017
Days to Decision 132 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 114d · This submission: 132d
Pathway characteristics
Standards-based clearance path.

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.