Cleared Traditional

Exofin High Viscosity Topical Skin Adhesive (K200264) - FDA 510(k) Clearance

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

K200264 · Chemence Medical, Inc. · General & Plastic Surgery device
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Dec 2020
Decision
318d
Days
Class 2
Risk

K200264 is an FDA 510(k) clearance for the Exofin High Viscosity Topical Skin Adhesive. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Chemence Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on December 17, 2020 after a review of 318 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 Chemence Medical, Inc. devices

Submission Details

510(k) Number K200264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2020
Decision Date December 17, 2020
Days to Decision 318 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
203d slower than avg
Panel avg: 115d · This submission: 318d
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 K200264.
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
LiquiBand Plus
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