Cleared Traditional

K970851 - LYOPLANT DURA SUBSTITUTE(VARIOUS)

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

K970851 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K970851

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.

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 K970851.
DURA-GUARD - DURAL REPAIR PATCH
K982282 · Bio-Vascular, Inc. · Jul 1998
DURA-PATCH MODEL DP-XXX
K980548 · Bridger Biomed, Inc. · May 1998
DURA-GUARD-DURAL REPAIR PATCH
K973706 · Bio-Vascular, Inc. · Dec 1997
NEURO-PATCH
K960470 · Aesculap, Inc. · May 1996
PRECLUDE DURA SUBSTITUTE
K953969 · W.L. Gore & Associates, Inc. · Nov 1995
DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
K950956 · Bio-Vascular, Inc. · Jun 1995