Clinical Neuro Systems Monitorr Icp Ventricular Ca

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922941 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Clinical Neuro Systems Monitorr Icp Lumbar Cathete

  Class II

  FDA 510(k) K922936 Active Cleared 26 Aug 1992

• Cns Interchangeable Bit Cranial Drill Open recall

  Class II

  FDA 510(k) K961113 Active Cleared 5 Jun 1996

• Clinical Neuro Systems Cranial Drill

  Class II

  FDA 510(k) K930229 Active Cleared 16 Mar 1993

• Clinical Neuro Syst Monitorr Ext Csf Drain/Moni Sy

  Class II

  FDA 510(k) K920156 Active Cleared 16 Mar 1992

• What clinical settings is the Monitorr ICP Ventricular Catheter designed for use in?

  The Monitorr ICP Ventricular Catheter is specifically intended for use in neurosurgical intensive care units (NICUs) and operating rooms. It is designed to measure intracranial pressure (ICP) and manage hydrocephalus by diverting cerebrospinal fluid (CSF) from the brain’s ventricular system to an external drainage system or internal reservoir.

• Is the Monitorr ICP Ventricular Catheter meant for single-use or can it be reused?

  The Monitorr ICP Ventricular Catheter is explicitly designed for single-use in clinical settings. It must be handled under aseptic conditions due to its sterile packaging, which aligns with its intended use in sterile environments like neurosurgical procedures.

• What are the key features of the regulatory clearance for this device?

  The Monitorr ICP Ventricular Catheter holds an FDA 510(k) clearance (K922941), granted in 1992 under the Traditional 510(k) review pathway. It is classified as a Class II medical device under FDA regulation 21 CFR 882.5550, with a substantially equivalent determination by the Neurology (NE) Advisory Committee. The product code assigned is JXG, reflecting its categorization as a shunt component for the central nervous system.

• How should the Monitorr ICP Ventricular Catheter be stored before use?

  The device is supplied sterile, so it must be stored in its original packaging to maintain sterility until use. Proper storage conditions—such as avoiding extreme temperatures or contamination—are critical, as the catheter is intended for immediate clinical use in sterile environments like operating rooms or NICUs.