Home / 510(k) Clearances / K062584

510(k) K062584

PRESSIO ICP MONITORING SYSTEM by Sophysa SA — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2007
Date Received
September 1, 2006
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 Sophysa SA

  • K250636 — Sophy Mini Monopressure Valve (SM1) (November 28, 2025)
  • K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet (June 20, 2025)
  • K222422 — Polaris Valve Electronic Reading Instrument (February 2, 2023)
  • K162108 — Pressio 2 ICP Monitoring System (April 17, 2017)
  • K141227 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX (April 2, 2015)
  • K091328 — SIPHONX GRAVITATIONAL ANTISIPHON DEVICE (January 22, 2010)
  • K090342 — POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV (August 11, 2009)
  • K042481 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 (December 14, 2004)
  • K031097 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB (February 26, 2004)
  • K013488 — SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 (March 27, 2002)

Other clearances for product code GWM

  • 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)
  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)
  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)