Cleared Special

K122118 - HAKIM PROGRAMMABLE AND PRECISION VALVE ...

K122118 is the FDA 510(k) clearance for HAKIM PROGRAMMABLE AND PRECISION VALVE ... by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Special 510(k) pathway after a 17-day FDA review.

K122118 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
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Aug 2012
Decision
17d
Days
Class 2
Risk

K122118 is an FDA 510(k) clearance for the HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM. 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 August 3, 2012 after a review of 17 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

Submission Details

510(k) Number K122118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2012
Decision Date August 03, 2012
Days to Decision 17 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
131d faster than avg
Panel avg: 148d · This submission: 17d
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 117
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