Cleared Traditional

K112567 - BIOMERIX ASSURE

K112567 is an FDA 510(k) clearance for BIOMERIX ASSURE, manufactured by Biomerix Corporation. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K112567 · Biomerix Corporation · General & Plastic Surgery device
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Dec 2011
Decision
112d
Days
Class 2
Risk

K112567 is an FDA 510(k) clearance for the BIOMERIX ASSURE. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Biomerix Corporation (Fremont, US). The FDA issued a Cleared decision on December 23, 2011 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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. Standard predicate reliance. 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 Biomerix Corporation devices

FDA 510(k) Submission Details - K112567

510(k) Number K112567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2011
Decision Date December 23, 2011
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTL Mesh, Surgical, Polymeric

All 212
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K112567.
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