Cleared Special

K082127 - STRATA NSC BURR HOLE VALVE, MODEL 42335

Also marketed or referenced as:
SHUNT ASSEMBLY, MODEL 46635

K082127 is an FDA 510(k) clearance for STRATA NSC BURR HOLE VALVE, manufactured by Medtronic Neurosurgery. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K082127

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K082127.
CODMAN HAKIM MICRO II VALVE
K091346 · Codman & Shurtleff, Inc. · Jun 2009
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
K090348 · Codman & Shurtleff, Inc. · Mar 2009
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
K083076 · Medtronic Neurosurgery · Nov 2008
SMALL LUMEN PERITONEAL CATHETER
K073139 · Medtronic Neurosurgery · Jan 2008
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
K072929 · Integra LifeSciences Corporation · Dec 2007
RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
K063836 · Medtronic Neurosurgery · Aug 2007