Cleared Traditional

K140517 - SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE

K140517 is an FDA 510(k) clearance for SURGISEAL TOPICAL SKIN ADHESIVE/SURGISE..., 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 59-day FDA review.

K140517 · Adhezion Biomedical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
59d
Days
Class 2
Risk

K140517 is an FDA 510(k) clearance for the SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS 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 28, 2014 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Adhezion Biomedical, LLC devices

FDA 510(k) Submission Details - K140517

510(k) Number K140517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2014
Decision Date April 28, 2014
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
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 K140517.
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
K133963 · Adhezion Biomedical, LLC · Sep 2014
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
BARLE TISSUE ADHESIVE 2
K132243 · Advanced Medical Solutions (Plymouth), Ltd. · Dec 2013
SURGISEAL TOPICAL SKIN ADHESIVE
K130329 · Adhezion Biomedical, LLC · Dec 2013
SURGISEAL TOPICAL SKIN ADHESIVE
K130474 · Adhezion Biomedical, LLC · May 2013