Cleared Traditional

K070961 - BIOMERIX SURGICAL MESH, MODEL: RCR-01

K070961 is an FDA 510(k) clearance for BIOMERIX 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 326-day FDA review.

K070961 · Biomerix Corporation · General & Plastic Surgery device
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Feb 2008
Decision
326d
Days
Class 2
Risk

K070961 is an FDA 510(k) clearance for the BIOMERIX SURGICAL MESH, MODEL: RCR-01. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Biomerix Corporation (Rockville, US). The FDA issued a Cleared decision on February 25, 2008 after a review of 326 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 878.3300 - 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. 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 Biomerix Corporation devices

FDA 510(k) Submission Details - K070961

510(k) Number K070961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2007
Decision Date February 25, 2008
Days to Decision 326 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
211d slower than avg
Panel avg: 115d · This submission: 326d
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 K070961.
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PREVADH MESH
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K071470 · Implantech Associates, Inc. · Aug 2007