Cleared Traditional

K110184 - LIQUIBAND FLOW CONTROL

K110184 is an FDA 510(k) clearance for LIQUIBAND FLOW CONTROL, manufactured by Medlogic Global Limited. The device is a Class 2 General & Plastic Surgery device with product code MPN cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K110184 · Medlogic Global Limited · General & Plastic Surgery device
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Dec 2011
Decision
329d
Days
Class 2
Risk

K110184 is an FDA 510(k) clearance for the LIQUIBAND FLOW CONTROL. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Medlogic Global Limited (Plympton, Plymouth, Devon, GB). The FDA issued a Cleared decision on December 16, 2011 after a review of 329 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 Medlogic Global Limited devices

FDA 510(k) Submission Details - K110184

510(k) Number K110184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2011
Decision Date December 16, 2011
Days to Decision 329 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
214d slower than avg
Panel avg: 115d · This submission: 329d
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.

Regulatory Peers - MPN Tissue Adhesive For The Topical Approximation Of Skin

All 13
Devices cleared under the same product code (MPN) and FDA review panel - the closest regulatory comparables to K110184.
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
K140343 · Aesculap, Inc. · May 2014
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
K121976 · Aesculap, Inc. · May 2013
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
K111959 · Aesculap, Inc. · Feb 2012
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
K100423 · Ethicon, Inc. · May 2010