Cleared Special

K082127 - STRATA NSC BURR HOLE VALVE

Also marketed or referenced as:
SHUNT ASSEMBLY, MODEL 46635

K082127 is the FDA 510(k) clearance for STRATA NSC BURR HOLE VALVE by Medtronic Neurosurgery. It is a Class 2 Neurology device (product code JXG) cleared through the Special 510(k) pathway after a 29-day FDA review.

K082127 · Medtronic Neurosurgery · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
29d
Days
Class 2
Risk

K082127 is an FDA 510(k) clearance for the STRATA NSC BURR HOLE VALVE, MODEL 42335. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on August 27, 2008 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Neurosurgery devices

Submission Details

510(k) Number K082127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2008
Decision Date August 27, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 157
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K082127.
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K072929 · Integra LifeSciences Corporation · Dec 2007
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
K062009 · Aesculap, Inc. · Jan 2007
CODMAN VPV SYSTEM, MODEL 82-3192
K061876 · Codman & Shurtleff, Inc. · Oct 2006