Cleared Traditional

K961859 - NOVUS STANDARD AND PEDIATRIC VALVES

K961859 is an FDA 510(k) clearance for NOVUS STANDARD AND PEDIATRIC VALVES, manufactured by Integra Neurocare, LLC. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K961859 · Integra Neurocare, LLC · Neurology device
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Dec 1996
Decision
216d
Days
Class 2
Risk

K961859 is an FDA 510(k) clearance for the NOVUS STANDARD AND PEDIATRIC VALVES. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Neurocare, LLC (Pleasant Prairie, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 216 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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 Integra Neurocare, LLC devices

FDA 510(k) Submission Details - K961859

510(k) Number K961859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1996
Decision Date December 16, 1996
Days to Decision 216 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 148d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 177
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K961859.
RADIONICS BURR HOLE VALVE
K970578 · Radionics, Inc. · Jun 1997
RADIONICS CONTOUR FLEX PLUS VALVE
K964386 · Radionics, Inc. · Jan 1997
CORDIS SHARP-ENDED STYLET
K955265 · Cordis Corp. · Dec 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159 · Cordis Corp. · Oct 1996
RADIONICS SIPHON LIMITING DEVICE (SLD)
K962990 · Radionics, Inc. · Oct 1996
VENTRICULAR CATHETER SET
K962097 · Cook, Inc. · Aug 1996