Cleared Traditional

Exofin Fusion Skin Closure System

K191461 · Chemence Medical, Inc. · General & Plastic Surgery

Jun 2020

Decision

368d

Days

Class 2

Risk

About This 510(k) Submission

K191461 is an FDA 510(k) clearance for the Exofin Fusion Skin Closure System, a Cutaneous Tissue Adhesive With Mesh (Class II — Special Controls, product code OMD), submitted by Chemence Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 5, 2020, 368 days after receiving the submission on June 3, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4011.

Submission Details

510(k) Number	K191461 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OMD — Cutaneous Tissue Adhesive With Mesh
Device Class	Class II — 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.