Cleared Special

K102589 - CODMAN BACTISEAL CATHETERS

K102589 is the FDA 510(k) clearance for CODMAN BACTISEAL CATHETERS by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Special 510(k) pathway after a 127-day FDA review.

K102589 · Codman & Shurtleff, Inc. · Neurology device
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Jan 2011
Decision
127d
Days
Class 2
Risk

K102589 is an FDA 510(k) clearance for the CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER. 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 January 14, 2011 after a review of 127 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K102589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2010
Decision Date January 14, 2011
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
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 K102589.
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
K101381 · Integra LifeSciences Corporation · Jul 2011
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
K110751 · Codman & Shurtleff, Inc. · May 2011
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS
K102961 · Codman & Shurtleff, Inc. · Feb 2011
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
K103003 · Aesculap, Inc. · Nov 2010
OSV II LOW FLOW LOW PRO VALVE
K093968 · Integra LifeSciences Corporation · Jan 2010
CODMAN HAKIM MICRO II VALVE
K091346 · Codman & Shurtleff, Inc. · Jun 2009