Cleared Special

K003564 - HAKIM PROGRAMMER AND TRANSMITTER

K003564 is the FDA 510(k) clearance for HAKIM PROGRAMMER AND TRANSMITTER by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Special 510(k) pathway after a 30-day FDA review.

K003564 · Codman & Shurtleff, Inc. · Neurology device
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Dec 2000
Decision
30d
Days
Class 2
Risk

K003564 is an FDA 510(k) clearance for the HAKIM PROGRAMMER AND TRANSMITTER. 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 December 20, 2000 after a review of 30 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 K003564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2000
Decision Date December 20, 2000
Days to Decision 30 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
118d faster than avg
Panel avg: 148d · This submission: 30d
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
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K003564.
CODMAN BACTISEAL EVD CATHETER SET
K021653 · Codman & Shurtleff, Inc. · Jul 2002
CODMAN HAKIM SHUNT SYSTEMS
K020667 · Codman & Shurtleff, Inc. · Mar 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · Aesculap, Inc. · Mar 2002
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · Radionics, Inc. · Aug 2000
SIPHONGUARD CSF CONTROL DEVICE
K992173 · Johnson & Johnson Professionals, Inc. · Apr 2000
RADIONICS LUMBOPERITONEAL SHUNT
K000057 · Radionics, Inc. · Mar 2000