Cleared Traditional

Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit

K153347 · Codman & Shurtleff, Inc. · Neurology
Aug 2016
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K153347 is an FDA 510(k) clearance for the Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on August 19, 2016, 273 days after receiving the submission on November 20, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K153347 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GWM — Device, Monitoring, Intracranial Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1620

Similar Devices — GWM Device, Monitoring, Intracranial Pressure

All 103
NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL
K250285 · Raumedic AG · Aug 2025
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K240821 · Braincare Desenvolvimento E Inova??o Tecnol?gica S.A. · Jul 2024
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890 · Integra Lifesciences Production Corporation · Feb 2024
B4C System
K201989 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 2021
CereLink ICP Monitor
K210993 · Integra Lifesciences Production Corporation · Apr 2021
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
K201118 · Medtronic, Inc. · May 2020

More from Codman & Shurtleff, Inc.

View all
CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
K193380 · NRY · Jul 2020
CERENOVUS Large Bore Catheter
K191237 · DQY · Nov 2019
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 · GWM · Nov 2017
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
K172537 · JXG · Oct 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022 · JXG · Oct 2017