Cleared Abbreviated

SURGISEAL TOPICAL SKIN ADHESIVE (K123936) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K123936 · Adhezion Biomedical, LLC · General & Plastic Surgery device
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Apr 2013
Decision
125d
Days
Class 2
Risk

K123936 is an FDA 510(k) clearance for the SURGISEAL 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 April 24, 2013 after a review of 125 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Adhezion Biomedical, LLC devices

Submission Details

510(k) Number K123936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2012
Decision Date April 24, 2013
Days to Decision 125 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 13
Devices cleared under the same product code (MPN) and FDA review panel - the closest regulatory comparables to K123936.
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
K152096 · Ethicon, Inc. · Oct 2015
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
K140343 · Aesculap, Inc. · May 2014
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
K121976 · Aesculap, Inc. · May 2013
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
K111959 · Aesculap, Inc. · Feb 2012
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
K100423 · Ethicon, Inc. · May 2010