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510(k) K022554

MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM by Integra Neurosciences — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2002
Date Received
August 2, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
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)
  • K022553 — CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MO (August 20, 2002)
  • K020558 — LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE (March 21, 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 JXG

  • K251598 — Intellidrop (December 10, 2025)
  • K250636 — Sophy Mini Monopressure Valve (SM1) (November 28, 2025)
  • K252514 — EVAC-MRI (November 5, 2025)
  • K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (August 8, 2025)
  • K243552 — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with (August 6, 2025)
  • K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet (June 20, 2025)
  • K243205 — EVAC (June 3, 2025)
  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (August 20, 2024)