Cleared Special

K031123 - CODMAN BACTISEAL BARIUM STRIPED CATHETERS

K031123 is an FDA 510(k) clearance for CODMAN BACTISEAL BARIUM STRIPED CATHETERS, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Neurology device with product code HCA cleared through the Special 510(k) pathway after a 35-day FDA review.

K031123 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
35d
Days
Class 2
Risk

K031123 is an FDA 510(k) clearance for the CODMAN BACTISEAL BARIUM STRIPED CATHETERS. Classified as Catheter, Ventricular (product code HCA), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on May 14, 2003 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4100 - 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 - K031123

510(k) Number K031123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2003
Decision Date May 14, 2003
Days to Decision 35 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
114d faster than avg
Panel avg: 149d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

HCA Device Classification - Class 2, Special Controls

Product Code HCA Catheter, Ventricular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4100
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 - HCA Catheter, Ventricular

All 9
Devices cleared under the same product code (HCA) and FDA review panel - the closest regulatory comparables to K031123.
Cleveland Multiport Ventricular Catheter Set
K161731 · Parker Hannifin Corp. · Mar 2017
SMARTFLOW CATHETER
K123605 · Mri Interventions, Inc. · Aug 2013
BRESAGEN CATHETER, MODEL CS-3000
K021481 · Bresagen, Inc. · Aug 2002
MIETHKE SHUNT SYSTEM
K020728 · Aesculap, Inc. · Apr 2002
ACT 11 MP VENTRICULAR CATHETER
K013005 · Innerspace, Inc. · Mar 2002
CODMAN BACTISEAL CATHETERS
K003322 · Codman & Shurtleff, Inc. · Oct 2001
K031123 · CODMAN BACTISEAL BARIUM STRIPED CATHETERS
Download PDF FDA Summary Codman & Shurtleff, I…