Cleared Traditional

SHELHIGH NO-REACT DURA SHIELD (K982101) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982101 · Shelhigh, Inc. · Neurology device
Download Printable Device Report (PDF)
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

Submission Details

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
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.

Device Classification

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 K982101.
Collagen Dura Regeneration Membrane - Repair
K251191 · Collagen Matrix, Inc. · Nov 2025
Helios Dura Regeneration Matrix
K250420 · Helios Biomedical, Inc. · May 2025
ArtiFascia
K223445 · Nurami Medical , Ltd. · Aug 2023
SyntheCel Dura Repair
K212943 · Synthes USA Products, LLC · Jan 2022
XenoSure Dura Biologic Patch
K183513 · LeMaitre Vascular, Inc. · Jun 2019
LYOPLANT ONLAY
K122791 · Aesculap, Inc. · Jun 2013