Cleared Traditional

K161050 - ACTABOND 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.

K161050 · Bergen Medical Products, Inc. · General & Plastic Surgery device
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Oct 2016
Decision
173d
Days
Class 2
Risk

K161050 is an FDA 510(k) clearance for the ACTABOND Topical Skin Adhesive. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Bergen Medical Products, Inc. (Cedar Knolls, US). The FDA issued a Cleared decision on October 4, 2016 after a review of 173 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 Bergen Medical Products, Inc. devices

Submission Details

510(k) Number K161050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2016
Decision Date October 04, 2016
Days to Decision 173 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
59d slower than avg
Panel avg: 114d · This submission: 173d
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 K161050.
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CUTIVA(TM) Topical Skin Adhesive (RM-1700)
K234114 · Okapi Medical, LLC Dba Resivant Medical · Aug 2024
CM005 Standard (CM005)
K233458 · Connexicon Medical , Ltd. · Jul 2024
Meriglu Topical Skin Adhesive
K230981 · M/s. Meril Endo Surgery Private Limited. · Mar 2024
Exofin Precision Pen
K212246 · Chemence Medical, Inc. · Sep 2021