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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
123d faster than avg
Panel avg: 149d · 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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K091346.
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
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
K090342 · Sophysa SA · Aug 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
OSV II
K081773 · Integra Neurosciences Implants S.A. · Nov 2008
K091346 · CODMAN HAKIM MICRO II VALVE
Download PDF FDA Summary Codman & Shurtleff, I…