Cleared Traditional

K153347 - Codman Microsensor Basic Kit

K153347 is the FDA 510(k) clearance for Codman Microsensor Basic Kit by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K153347 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
273d
Days
Class 2
Risk

K153347 is an FDA 510(k) clearance for the Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codm.... Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on August 19, 2016 after a review of 273 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K153347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2015
Decision Date August 19, 2016
Days to Decision 273 days
Submission Type Traditional
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
125d slower than avg
Panel avg: 148d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
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 - GWM Device, Monitoring, Intracranial Pressure

All 34
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K153347.
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · Integra Lifesciences Corp. · Jan 2019
AURA ICP MONITORING SYSTEM
K172209 · Branchpoint Technologies, Inc. · May 2018
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
K173192 · Codman & Shurtleff, Inc. · Nov 2017
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
K152670 · Medos International SARL · Jan 2016
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
K133754 · Integra LifeSciences Corporation · Mar 2014
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875 · Integra LifeSciences Corporation · Dec 2010