Cleared Traditional

K121976 - AESCULAP HISTOACRYL FLEXIBLE TOPICAL SK...

K121976 is the FDA 510(k) clearance for AESCULAP HISTOACRYL FLEXIBLE TOPICAL SK... by Aesculap, Inc.. It is a Class 2 General & Plastic Surgery device (product code MPN) cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K121976 · Aesculap, Inc. · General & Plastic Surgery device
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May 2013
Decision
316d
Days
Class 2
Risk

K121976 is an FDA 510(k) clearance for the AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on May 17, 2013 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aesculap, Inc. devices

Submission Details

510(k) Number K121976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2012
Decision Date May 17, 2013
Days to Decision 316 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
201d slower than avg
Panel avg: 115d · This submission: 316d
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 12
Devices cleared under the same product code (MPN) and FDA review panel - the closest regulatory comparables to K121976.
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K183570 · Advanced Medical Solutions Limited · Mar 2020
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 AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
K111959 · Aesculap, Inc. · Feb 2012
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
K100423 · Ethicon, Inc. · May 2010