Cleared Traditional

LYOPLANT DURA SUBSTITUTE(VARIOUS) (K970851) - FDA 510(k) Clearance

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

K970851 · Aesculap, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 1997
Decision
277d
Days
Class 2
Risk

K970851 is an FDA 510(k) clearance for the LYOPLANT DURA SUBSTITUTE(VARIOUS). Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 9, 1997 after a review of 277 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 Aesculap, Inc. devices

Submission Details

510(k) Number K970851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1997
Decision Date December 09, 1997
Days to Decision 277 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
129d slower than avg
Panel avg: 148d · This submission: 277d
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 K970851.
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