Cleared Special

Exofin Precision Pen

K212246 · Chemence Medical, Inc. · General & Plastic Surgery

Sep 2021

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K212246 is an FDA 510(k) clearance for the Exofin Precision Pen, a Tissue Adhesive For The Topical Approximation Of Skin (Class II — Special Controls, product code MPN), submitted by Chemence Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 9, 2021, 52 days after receiving the submission on July 19, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4010.

Submission Details

510(k) Number	K212246 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2021
Decision Date	September 09, 2021
Days to Decision	52 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	MPN — Tissue Adhesive For The Topical Approximation Of Skin
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4010
Definition	Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k).