Cleared Traditional

K152096 - DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive

K152096 is an FDA 510(k) clearance for DERMABOND Advanced Topical Skin Adhesive, manufactured by Ethicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MPN cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K152096 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
86d
Days
Class 2
Risk

K152096 is an FDA 510(k) clearance for the DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topic.... Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on October 22, 2015 after a review of 86 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.

FDA 510(k) Submission Details - K152096

510(k) Number K152096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2015
Decision Date October 22, 2015
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 K152096.
GluStitch Twist Tissue Adhesive
K150032 · Glustitch, Inc. · Jan 2016
BONDEASE TOPICAL SKIN ADHESIVE
K141157 · Optmed, Inc. · Dec 2015
LiquiBand Exceed
K151182 · Advanced Medical Solutions (Plymouth), Ltd. · Oct 2015
SURGISEAL Topical Skin Adhesvie
K150866 · Adhezion Biomedical, LLC · Jul 2015
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
K133963 · Adhezion Biomedical, LLC · Sep 2014
SURGISEAL TWIST TOPICAL SKIN ADHESIVE
K141215 · Adhezion Biomedical, LLC · Aug 2014
K152096 · DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
Download PDF FDA Summary Ethicon, Inc.