Cleared Traditional

BARLE TISSUE ADHESIVE 2

K132243 · Advanced Medical Solutions (Plymouth), Ltd. · General & Plastic Surgery

Dec 2013

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K132243 is an FDA 510(k) clearance for the BARLE TISSUE ADHESIVE 2, a Tissue Adhesive For The Topical Approximation Of Skin (Class II — Special Controls, product code MPN), submitted by Advanced Medical Solutions (Plymouth), Ltd. (Plympton, Plymouth, Devon, GB). The FDA issued a Cleared decision on December 20, 2013, 155 days after receiving the submission on July 18, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4010.

Submission Details

510(k) Number	K132243 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2013
Decision Date	December 20, 2013
Days to Decision	155 days
Submission Type	Traditional
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).