Cleared Traditional

K191461 - Exofin Fusion Skin Closure System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191461 · Chemence Medical, Inc. · General & Plastic Surgery device
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Jun 2020
Decision
368d
Days
Class 2
Risk

K191461 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 June 5, 2020 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Chemence Medical, Inc. devices

Submission Details

510(k) Number K191461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2019
Decision Date June 05, 2020
Days to Decision 368 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 114d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.