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

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
122d faster than avg
Panel avg: 149d · 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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K020667.
PERF (OMMAYA STYLE) RESERVOIRS
K021644 · Phoenix Biomedical Corp. · Aug 2002
CODMAN BACTISEAL EVD CATHETER SET
K021653 · Codman & Shurtleff, Inc. · Jul 2002
NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
K021196 · Neuron Therapeutics, Inc. · Jul 2002
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
K013488 · Sophysa SA · Mar 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · Aesculap, Inc. · Mar 2002
MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
K012052 · Medtronic PS Medical · Feb 2002
K020667 · CODMAN HAKIM SHUNT SYSTEMS
Download PDF FDA Summary Codman & Shurtleff, I…