Cleared Traditional

K141215 - SURGISEAL TWIST TOPICAL SKIN ADHESIVE

K141215 is an FDA 510(k) clearance for SURGISEAL TWIST TOPICAL SKIN ADHESIVE, manufactured by Adhezion Biomedical, LLC. The device is a Class 2 General & Plastic Surgery device with product code MPN cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K141215 · Adhezion Biomedical, LLC · General & Plastic Surgery device
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Aug 2014
Decision
101d
Days
Class 2
Risk

K141215 is an FDA 510(k) clearance for the SURGISEAL TWIST TOPICAL SKIN ADHESIVE. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Adhezion Biomedical, LLC (Wyomissing, US). The FDA issued a Cleared decision on August 21, 2014 after a review of 101 days - within the typical 510(k) review window.

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.

View all Adhezion Biomedical, LLC devices

FDA 510(k) Submission Details - K141215

510(k) Number K141215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2014
Decision Date August 21, 2014
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
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 K141215.
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
K152096 · Ethicon, Inc. · Oct 2015
SURGISEAL Topical Skin Adhesvie
K150866 · Adhezion Biomedical, LLC · Jul 2015
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
K133963 · Adhezion Biomedical, LLC · Sep 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
BARLE TISSUE ADHESIVE 2
K132243 · Advanced Medical Solutions (Plymouth), Ltd. · Dec 2013