Cleared Special

K173192 - 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 is an FDA 510(k) clearance for CereLink ICP Sensor Basic Kit, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Special 510(k) pathway after a 37-day FDA review.

K173192 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
37d
Days
Class 2
Risk

K173192 is an FDA 510(k) clearance for the CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, Cere.... 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 November 8, 2017 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - 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 - K173192

510(k) Number K173192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date November 08, 2017
Days to Decision 37 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
112d faster than avg
Panel avg: 149d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

GWM Device Classification - Class 2, Special Controls

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 94
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K173192.
BcSs-PICNI-2000 Sensor
K182073 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · Integra Lifesciences Corp. · Jan 2019
AURA ICP MONITORING SYSTEM
K172209 · Branchpoint Technologies, Inc. · May 2018
MPR2 logO DATALOGGER
K171666 · Raumedic AG · Jul 2017
Pressio 2 ICP Monitoring System
K162108 · Sophysa SA · Apr 2017
HICP200 Patient/Monitor Interconnect Cable
K161010 · Innerspace Neuro Solutions, Inc. · Oct 2016
K173192 · 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
Download PDF FDA Summary Codman & Shurtleff, I…