Cleared Traditional

K131015 - BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT

K131015 is an FDA 510(k) clearance for BIODESIGN ONLAY DURAL GRAFT OR BIODESIG..., manufactured by Cook Biotech, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K131015 · Cook Biotech, Inc. · Neurology device
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Oct 2013
Decision
180d
Days
Class 2
Risk

K131015 is an FDA 510(k) clearance for the BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on October 8, 2013 after a review of 180 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Biotech, Inc. devices

FDA 510(k) Submission Details - K131015

510(k) Number K131015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2013
Decision Date October 08, 2013
Days to Decision 180 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 148d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXQ Device Classification - Class 2, Special Controls

Product Code GXQ Dura Substitute
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5910
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 Neurology devices follow this clearance model.

Regulatory Peers - GXQ Dura Substitute

All 42
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K131015.
COLLAGEN DURA MEMBRANE
K141608 · Collagen Matrix, Inc. · Jan 2015
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
K132850 · Rti Surgical, Inc. · Mar 2014
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
K131792 · Synthes, Inc. · Dec 2013
LYOPLANT ONLAY
K122791 · Aesculap, Inc. · Jun 2013
DURAGEN SECURE DURAL REGNERATION MATRIX
K120600 · Integra Life Sciences · Jun 2012
SYNTHECEL DURA REPLACEMENT DEVICES
K113071 · Synthes · Jan 2012