Home / 510(k) Clearances / K010422

510(k) K010422

ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER by Innerspace, Inc. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2001
Date Received
February 12, 2001
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 Innerspace, Inc.

  • K113088 — HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP (May 2, 2012)
  • K083378 — SYNERGY (September 29, 2009)
  • K072379 — MPS OXIPORT AND MPS OXIPORT PLUS (April 29, 2008)
  • K041838 — MPS (OR MPS-T) (March 1, 2005)
  • K013705 — ACT III VENTRICULAR CATHETER (September 9, 2002)
  • K013005 — ACT 11 MP VENTRICULAR CATHETER (March 8, 2002)
  • K003905 — ACTI-ICP MONITORING SYSTEM (June 15, 2001)

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)