Cleared Traditional

K133306 - SIS HERNIA GRAFT

K133306 is an FDA 510(k) clearance for SIS HERNIA GRAFT, manufactured by Cook Biotech, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K133306 · Cook Biotech, Inc. · General & Plastic Surgery device
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Jul 2014
Decision
268d
Days
Class 2
Risk

K133306 is an FDA 510(k) clearance for the SIS HERNIA GRAFT. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on July 23, 2014 after a review of 268 days - an extended review cycle.

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 Cook Biotech, Inc. devices

FDA 510(k) Submission Details - K133306

510(k) Number K133306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2013
Decision Date July 23, 2014
Days to Decision 268 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 115d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 133
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K133306.
OVINE TISSUE MATRIX(OTM)
K141053 · TELA Bio, Inc. · Dec 2014
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
K142070 · Rti Surgical, Inc. · Oct 2014
CORMATRIX PROTECT ECM ENVELOPE
K140306 · Cormatrix Cardiovascular, Inc. · Aug 2014
XENMATRIX SURGICAL GRAFT
K140501 · C. R. Bard · Apr 2014
MIROMATRIX BIOLOGICAL MESH
K134033 · Miromatrix Medical, Inc. · Mar 2014
MESO BILAYER SURGICAL MESH
K132025 · Kensey Nash Corporation Dba Dsm Biomedical · Oct 2013