Cleared Special

K133963 - SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K133963 · Adhezion Biomedical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Sep 2014
Decision
259d
Days
Class 2
Risk

K133963 is an FDA 510(k) clearance for the SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE. 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 September 9, 2014 after a review of 259 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Adhezion Biomedical, LLC devices

Submission Details

510(k) Number K133963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2013
Decision Date September 09, 2014
Days to Decision 259 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 114d · This submission: 259d
Pathway characteristics
Modification to existing cleared device.

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
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