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510(k) K020558

LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE by Integra Neurosciences — Product Code GWM

K020558 is an FDA 510(k) premarket notification submitted by Integra Neurosciences for the device "LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE". The FDA issued a decision of Substantially Equivalent on March 21, 2002. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Integra Neurosciences has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2002
Date Received
February 20, 2002
Clearance Type
Special
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 Integra Neurosciences

  • K082250 — AURAGEN CORTICAL SURFACE ELECTRODES (October 10, 2008)
  • K050720 — NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, (May 11, 2005)
  • K042277 — SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM (September 29, 2004)
  • K031086 — CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 (May 14, 2003)
  • K021989 — SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 (September 13, 2002)
  • K022554 — MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (August 23, 2002)
  • K022553 — CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MO (August 20, 2002)
  • K002765 — LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTROD (November 24, 2000)

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

FDA data resources