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510(k) K182073

BcSs-PICNI-2000 Sensor by Braincare Desenvolvimento E Inovacao Tecnologica S.A. — Product Code GWM

K182073 is an FDA 510(k) premarket notification submitted by Braincare Desenvolvimento E Inovacao Tecnologica S.A. for the device "BcSs-PICNI-2000 Sensor". The FDA issued a decision of Substantially Equivalent on October 17, 2019. 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 17, 2019
Date Received
August 1, 2018
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.

  • K201989 — B4C System (October 8, 2021)

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)
  • 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)
  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)

FDA data resources