Cleared Special

K091346 - CODMAN HAKIM MICRO II VALVE

K091346 is an FDA 510(k) clearance for CODMAN HAKIM MICRO II VALVE, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 26-day FDA review.

K091346 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
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Jun 2009
Decision
26d
Days
Class 2
Risk

K091346 is an FDA 510(k) clearance for the CODMAN HAKIM MICRO II VALVE. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on June 2, 2009 after a review of 26 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 Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K091346

510(k) Number K091346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2009
Decision Date June 02, 2009
Days to Decision 26 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
122d faster than avg
Panel avg: 148d · This submission: 26d
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 207
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K091346.
OSV II LOW FLOW LOW PRO VALVE
K093968 · Integra LifeSciences Corporation · Jan 2010
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
K092395 · Integra Lifesciences Corp. · Nov 2009
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K091312 · Medtronic Neurosurgery · Sep 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
STRATA NSC BURR HOLE VALVE, MODEL 42335
K082127 · Medtronic Neurosurgery · Aug 2008