Cleared Traditional

K970851 - LYOPLANT DURA SUBSTITUTE(VARIOUS)

K970851 is the FDA 510(k) clearance for LYOPLANT DURA SUBSTITUTE(VARIOUS) by Aesculap, Inc.. It is a Class 2 Neurology device (product code GXQ) cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K970851 · Aesculap, Inc. · Neurology device
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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
Combination Product No
PCCP Authorized No
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 19
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K970851.
PRECLUDE MVP DURA SUBSTITUTE
K021477 · W.L. Gore & Associates, Inc. · Nov 2002
CODMAN ETHISORB DURA PATCH
K991413 · Johnson & Johnson Professionals, Inc. · Mar 2000
PRECLUDE ACUSEAL DURA SUBSTITUTE
K984534 · W.L. Gore & Associates, Inc. · Mar 1999
NEURO-PATCH
K960470 · Aesculap, Inc. · May 1996
PRECLUDE DURA SUBSTITUTE
K953969 · W.L. Gore & Associates, Inc. · Nov 1995