Cleared Traditional

K132243 - BARLE TISSUE ADHESIVE 2

K132243 is an FDA 510(k) clearance for BARLE TISSUE ADHESIVE 2, manufactured by Advanced Medical Solutions (Plymouth), Ltd.. The device is a Class 2 General & Plastic Surgery device with product code MPN cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K132243 · Advanced Medical Solutions (Plymouth), Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
155d
Days
Class 2
Risk

K132243 is an FDA 510(k) clearance for the BARLE TISSUE ADHESIVE 2. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Advanced Medical Solutions (Plymouth), Ltd. (Plympton, Plymouth, Devon, GB). The FDA issued a Cleared decision on December 20, 2013 after a review of 155 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4010 - 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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K132243

510(k) Number K132243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 115d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPN Device Classification - Class 2, Special Controls

Product Code MPN Tissue Adhesive For The Topical Approximation Of Skin
Device Class Class 2 - 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).
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.

Regulatory Peers - MPN Tissue Adhesive For The Topical Approximation Of Skin

All 35
Devices cleared under the same product code (MPN) and FDA review panel - the closest regulatory comparables to K132243.
SURGISEAL TWIST TOPICAL SKIN ADHESIVE
K141215 · Adhezion Biomedical, LLC · Aug 2014
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
K140343 · Aesculap, Inc. · May 2014
SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
K140517 · Adhezion Biomedical, LLC · Apr 2014
SURGISEAL TOPICAL SKIN ADHESIVE
K130329 · Adhezion Biomedical, LLC · Dec 2013
SURGISEAL TOPICAL SKIN ADHESIVE
K130474 · Adhezion Biomedical, LLC · May 2013
BARLE TISSUE ADHESIVE
K123133 · Advanced Medical Solutions (Plymouth), Ltd. · May 2013