B4C System - Addition of new sensor model (BcSs-PICNIW-2000)

Q: What is the product code of K240821?

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

FDA 510(k) K240821 · Braincare Desenvolvimento E Inovação Tecnológica S.A.

Substantially Equivalent

510(k) numberK240821

Submission

Device name: B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
Applicant: Braincare Desenvolvimento E Inovação Tecnológica S.A.
São Carlos, BR
Received: March 25, 2024
Decision date: July 18, 2024
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)	Device	Applicant	Decision
K252241	Pressio 3 Multi-parameter Neuromonitoring SystemGWM · Traditional	Sophysa	04/10/2026SE
K250285	Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…GWM · Traditional	Raumedic AG	08/29/2025SE
K232890	CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM · Traditional	Integra Lifesciences Production Corporation	02/04/2024SE
K201989	B4C SystemGWM · Traditional	Braincare Desenvolvimento E Inovacao Tecnologica…	10/08/2021SE
K210993	CereLink ICP MonitorGWM · Special	Integra Lifesciences Production Corporation	04/30/2021SE
K201118	Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta…GWM · Special	Medtronic, Inc.	05/26/2020SE
K200630	Medtronic External Drainage and Monitoring System, Medtronic External Drainage and…GWM · Special	Medtronic, Inc.	04/09/2020SE
K200456	Becker External Drainage and Monitoring SystemGWM · Special	Medtronic, Inc.	03/26/2020SE
K182073	BcSs-PICNI-2000 SensorGWM · Traditional	Braincare Desenvolvimento E Inovacao Tecnologica…	10/17/2019SE
K183406	CereLink ICP Monitor, CereLink ICP Extension CableGWM · Special	Integra Lifesciences Corp.	01/11/2019SE

Questions and answers

When was B4C System - Addition of new sensor model (BcSs-PICNIW-2000) cleared by the FDA?

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (K240821) received a 510(k) decision of Substantially Equivalent on July 18, 2024, 115 days after the submission was received.

What is the product code of K240821?

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