Cleared Traditional

K161011 - SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161011 · Adhezion Biomedical, LLC · General & Plastic Surgery device
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Nov 2016
Decision
211d
Days
Class 2
Risk

K161011 is an FDA 510(k) clearance for the SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURG.... 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 November 8, 2016 after a review of 211 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.

View all Adhezion Biomedical, LLC devices

Submission Details

510(k) Number K161011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2016
Decision Date November 08, 2016
Days to Decision 211 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 114d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 35
Devices cleared under the same product code (MPN) and FDA review panel - the closest regulatory comparables to K161011.
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K233458 · Connexicon Medical , Ltd. · Jul 2024
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K230981 · M/s. Meril Endo Surgery Private Limited. · Mar 2024
Exofin Precision Pen
K212246 · Chemence Medical, Inc. · Sep 2021