Cleared Traditional

K131007 - AIGIS RX N MEDIUM

Also marketed or referenced as:
AIGIS RX N LARGE

K131007 is an FDA 510(k) clearance for AIGIS RX N MEDIUM, manufactured by Tyrx, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K131007 · Tyrx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
90d
Days
Class 2
Risk

K131007 is an FDA 510(k) clearance for the AIGIS RX N MEDIUM. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Tyrx, Inc. (Monmouth Junction, US). The FDA issued a Cleared decision on July 10, 2013 after a review of 90 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 Tyrx, Inc. devices

FDA 510(k) Submission Details - K131007

510(k) Number K131007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2013
Decision Date July 10, 2013
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 204
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K131007.
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K130968 · C.R. Bard, Inc. · May 2013
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K123479 · Sofradim Production · Dec 2012
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K122436 · C.R. Bard, Inc. · Nov 2012