Cleared Traditional

K982180 - DURAGEN DURAL GRAFT MATRIX

K982180 is an FDA 510(k) clearance for DURAGEN DURAL GRAFT MATRIX, manufactured by Integra Lifesciences Corp.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K982180 · Integra Lifesciences Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
379d
Days
Class 2
Risk

K982180 is an FDA 510(k) clearance for the DURAGEN DURAL GRAFT MATRIX. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on July 6, 1999 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Integra Lifesciences Corp. devices

FDA 510(k) Submission Details - K982180

510(k) Number K982180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1998
Decision Date July 06, 1999
Days to Decision 379 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
231d slower than avg
Panel avg: 148d · This submission: 379d
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 41
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K982180.
PRECLUDE MVP DURA SUBSTITUTE
K021477 · W.L. Gore & Associates, Inc. · Nov 2002
SHELHIGH NO-REACT DURA SHIELD
K982101 · Shelhigh, Inc. · May 2000
CODMAN ETHISORB DURA PATCH
K991413 · Johnson & Johnson Professionals, Inc. · Mar 2000
PRECLUDE ACUSEAL DURA SUBSTITUTE
K984534 · W.L. Gore & Associates, Inc. · Mar 1999
DURA-GUARD - DURAL REPAIR PATCH
K982282 · Bio-Vascular, Inc. · Jul 1998
DURA-PATCH MODEL DP-XXX
K980548 · Bridger Biomed, Inc. · May 1998