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510(k) K201989

B4C System by Braincare Desenvolvimento E Inovacao Tecnologica S.A. — Product Code GWM

K201989 is an FDA 510(k) premarket notification submitted by Braincare Desenvolvimento E Inovacao Tecnologica S.A. for the device "B4C System". The FDA issued a decision of Substantially Equivalent on October 8, 2021. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Braincare Desenvolvimento E Inovacao Tecnologica S.A. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2021
Date Received
July 17, 2020
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

Other clearances by Braincare Desenvolvimento E Inovacao Tecnologica S.A.

  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)

Other clearances for product code GWM

  • K252241 — Pressio 3 Multi-parameter Neuromonitoring System (April 10, 2026)
  • K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); (August 29, 2025)
  • K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (July 18, 2024)
  • K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (February 4, 2024)
  • 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