Cleared Traditional

K132850 - BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM

K132850 is an FDA 510(k) clearance for BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, manufactured by Rti Surgical, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K132850 · Rti Surgical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
201d
Days
Class 2
Risk

K132850 is an FDA 510(k) clearance for the BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVIN.... Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on March 31, 2014 after a review of 201 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 Rti Surgical, Inc. devices

FDA 510(k) Submission Details - K132850

510(k) Number K132850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2013
Decision Date March 31, 2014
Days to Decision 201 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
52d slower than avg
Panel avg: 149d · This submission: 201d
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 K132850.
Collagen Dural Regeneration Matrix
K150825 · Collagen Matrix, Inc. · Nov 2015
DURAFORM Dural Graft Implant
K152481 · Codman & Shurtleff, Inc. · Oct 2015
COLLAGEN DURA MEMBRANE
K141608 · Collagen Matrix, Inc. · Jan 2015
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
K131792 · Synthes, Inc. · Dec 2013
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015 · Cook Biotech, Inc. · Oct 2013
LYOPLANT ONLAY
K122791 · Aesculap, Inc. · Jun 2013