Cleared Traditional

K083531 - LIQUIBAND ULTIMA, MODEL LB0004

K083531 is an FDA 510(k) clearance for LIQUIBAND ULTIMA, manufactured by Medlogic Global , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code MPN cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K083531 · Medlogic Global , Ltd. · General & Plastic Surgery device
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Feb 2009
Decision
76d
Days
Class 2
Risk

K083531 is an FDA 510(k) clearance for the LIQUIBAND ULTIMA, MODEL LB0004. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Medlogic Global , Ltd. (Minneapolis, US). The FDA issued a Cleared decision on February 12, 2009 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medlogic Global , Ltd. devices

FDA 510(k) Submission Details - K083531

510(k) Number K083531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2008
Decision Date February 12, 2009
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPN Device Classification - Class 2, Special Controls

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.