Cleared Traditional

K960470 - NEURO-PATCH

K960470 is an FDA 510(k) clearance for NEURO-PATCH, 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 99-day FDA review.

K960470 · Aesculap, Inc. · Neurology device
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May 1996
Decision
99d
Days
Class 2
Risk

K960470 is an FDA 510(k) clearance for the NEURO-PATCH. 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 May 10, 1996 after a review of 99 days - within the typical 510(k) review window.

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 - K960470

510(k) Number K960470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1996
Decision Date May 10, 1996
Days to Decision 99 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
49d faster than avg
Panel avg: 148d · This submission: 99d
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 K960470.
DURA-PATCH MODEL DP-XXX
K980548 · Bridger Biomed, Inc. · May 1998
DURA-GUARD-DURAL REPAIR PATCH
K973706 · Bio-Vascular, Inc. · Dec 1997
LYOPLANT DURA SUBSTITUTE(VARIOUS)
K970851 · Aesculap, Inc. · Dec 1997
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