Cleared Special

K020667 - CODMAN HAKIM SHUNT SYSTEMS

K020667 is an FDA 510(k) clearance for CODMAN HAKIM SHUNT SYSTEMS, 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 27-day FDA review.

K020667 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
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Mar 2002
Decision
27d
Days
Class 2
Risk

K020667 is an FDA 510(k) clearance for the CODMAN HAKIM SHUNT SYSTEMS. 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 March 28, 2002 after a review of 27 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 - K020667

510(k) Number K020667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date March 28, 2002
Days to Decision 27 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
121d faster than avg
Panel avg: 148d · This submission: 27d
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 206
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K020667.
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
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HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
K030289 · Integra Lifesciences Corp. · Feb 2003
CODMAN BACTISEAL EVD CATHETER SET
K021653 · Codman & Shurtleff, Inc. · Jul 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · Aesculap, Inc. · Mar 2002
HAKIM PROGRAMMER AND TRANSMITTER
K003564 · Codman & Shurtleff, Inc. · Dec 2000
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
K992465 · Sophysa SA · Sep 2000