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510(k) K240821

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) by Braincare Desenvolvimento E Inovação Tecnológica S.A. — Product Code GWM

K240821 is an FDA 510(k) premarket notification submitted by Braincare Desenvolvimento E Inovação Tecnológica S.A. for the device "B4C System - Addition of new sensor model (BcSs-PICNIW-2000)". The FDA issued a decision of Substantially Equivalent on July 18, 2024. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2024
Date Received
March 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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  • K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); (August 29, 2025)
  • K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (February 4, 2024)
  • K201989 — B4C System (October 8, 2021)
  • K210993 — CereLink ICP Monitor (April 30, 2021)
  • K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Ex (May 26, 2020)
  • K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage a (April 9, 2020)
  • K200456 — Becker External Drainage and Monitoring System (March 26, 2020)
  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)
  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)

FDA data resources