Cleared Traditional

K082941 - BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215

K082941 is an FDA 510(k) clearance for BIOMERIX COMPOSITE SURGICAL MESH, 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 97-day FDA review.

K082941 · Biomerix Corporation · General & Plastic Surgery device
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Jan 2009
Decision
97d
Days
Class 2
Risk

K082941 is an FDA 510(k) clearance for the BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215. 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 January 7, 2009 after a review of 97 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 - K082941

510(k) Number K082941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2008
Decision Date January 07, 2009
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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 K082941.
GORE BIO-A FISTULA PLUG
K083266 · W.L. Gore & Associates, Inc. · Mar 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc. · Jan 2009
ATRIUM PROLITE S MESH
K082748 · Atrium Medical Corp. · Jan 2009
BARD 3DMAX MESH
K081010 · Davol Inc., Sub. C. R. Bard, Inc. · Oct 2008
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc. · Sep 2008
SUPRAMESH EXTRA
K080216 · S. Jackson, Inc. · Sep 2008