Cleared Traditional

K982101 - SHELHIGH NO-REACT DURA SHIELD

K982101 is an FDA 510(k) clearance for SHELHIGH NO-REACT DURA SHIELD, manufactured by Shelhigh, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 687-day FDA review.

K982101 · Shelhigh, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
May 2000
Decision
687d
Days
Class 2
Risk

K982101 is an FDA 510(k) clearance for the SHELHIGH NO-REACT DURA SHIELD. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Shelhigh, Inc. (Millburn, US). The FDA issued a Cleared decision on May 2, 2000 after a review of 687 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Shelhigh, Inc. devices

FDA 510(k) Submission Details - K982101

510(k) Number K982101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date May 02, 2000
Days to Decision 687 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
539d slower than avg
Panel avg: 148d · This submission: 687d
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 34
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K982101.
DURAGEN PLUS DURAL GRAFT MATRIX
K032693 · Integra Lifesciences Corp. · Sep 2003
DURASIS DURAL SUBSTITUTE
K031850 · Cook Biotech, Inc. · Sep 2003
PRECLUDE MVP DURA SUBSTITUTE
K021477 · W.L. Gore & Associates, Inc. · Nov 2002
CODMAN ETHISORB DURA PATCH
K991413 · Johnson & Johnson Professionals, Inc. · Mar 2000
DURAGEN DURAL GRAFT MATRIX
K982180 · Integra Lifesciences Corp. · Jul 1999
PRECLUDE ACUSEAL DURA SUBSTITUTE
K984534 · W.L. Gore & Associates, Inc. · Mar 1999