B4C System

FDA 510(k) K201989 · Braincare Desenvolvimento E Inovacao Tecnologica S.A.

Substantially Equivalent

510(k) numberK201989

Submission

Device name
B4C System
Applicant
Braincare Desenvolvimento E Inovacao Tecnologica S.A.
São Carlos, BR
Received
July 17, 2020
Decision date
October 8, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWM – Device, Monitoring, Intracranial Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1620
Specialty
Neurology

Other 510(k)s with product code GWM

510(k)DeviceApplicantDecision
K252241Pressio 3 Multi-parameter Neuromonitoring SystemGWM · Traditional Sophysa04/10/2026SE
K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…GWM · Traditional Raumedic AG08/29/2025SE
K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)GWM · Traditional Braincare Desenvolvimento E Inovação Tecnológica…07/18/2024SE
K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM · Traditional Integra Lifesciences Production Corporation02/04/2024SE
K210993CereLink ICP MonitorGWM · Special Integra Lifesciences Production Corporation04/30/2021SE
K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta…GWM · Special Medtronic, Inc.05/26/2020SE
K200630Medtronic External Drainage and Monitoring System, Medtronic External Drainage and…GWM · Special Medtronic, Inc.04/09/2020SE
K200456Becker External Drainage and Monitoring SystemGWM · Special Medtronic, Inc.03/26/2020SE
K182073BcSs-PICNI-2000 SensorGWM · Traditional Braincare Desenvolvimento E Inovacao Tecnologica…10/17/2019SE
K183406CereLink ICP Monitor, CereLink ICP Extension CableGWM · Special Integra Lifesciences Corp.01/11/2019SE

More from Integra Lifesciences Corp.

510(k)DeviceDecision
K182073BcSs-PICNI-2000 SensorGWM · Traditional 10/17/2019SE

Questions and answers

When was B4C System cleared by the FDA?

B4C System (K201989) received a 510(k) decision of Substantially Equivalent on October 8, 2021, 448 days after the submission was received.

What is the product code of K201989?

The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.