1.2MM Reusable NeuroView Endoscope

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

510(k) Number

K961173 ↗

FDA Product Code

GWG

Device Class

Class II

Regulation

21 CFR Part 882.1480

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Disposable Aspiration/Irrigation Catheter

  Class II

  FDA 510(k) K934154 Active Cleared 21 Feb 1995

• Neuroview Scissors

  Class II

  FDA 510(k) K961406 Active Cleared 13 Jun 1996

• Disposable Bipolar Electrode

  Class II

  FDA 510(k) K942955 Active Cleared 3 Aug 1994

• Integrated Visualization System

  Class I

  FDA 510(k) K925108 Active Cleared 29 Jan 1993

• Disposable Neuroview Endoscope

  Class II

  FDA 510(k) K923479 Active Cleared 19 Feb 1993

• 1.2mm Disposable Neuroview Preformed Endoscope

  Class II

  FDA 510(k) K950705 Active Cleared 9 May 1995

See all devices from Neuro Navigational Corp. →

• Is this endoscope designed for single-use or reusable applications, and what does that mean for my facility’s workflow?

  This device is explicitly designed for reusable applications, meaning it must be cleaned, disinfected, and sterilized between uses according to established medical device reprocessing protocols. Since it’s reusable, your facility will need to integrate it into your existing reprocessing workflows, including proper cleaning, sterilization (e.g., autoclave or chemical sterilization), and maintenance to ensure safety and functionality. The manufacturer provides instructions for handling and reprocessing, which must be followed strictly to maintain sterility and performance.

• What is the diameter of the 1.2mm NeuroView Endoscope, and how might this affect its use in delicate neurosurgical procedures?

  The device’s name includes 1.2mm, which refers to its outer diameter—a critical specification for minimally invasive neurosurgery. This slim profile allows for insertion into confined or delicate anatomical spaces, such as the brain or spinal cord, reducing trauma to surrounding tissues. Its rigid design also ensures stable imaging during procedures like biopsies, tumor resections, or vascular interventions where precision is essential.

• Where is this endoscope manufactured, and how can I verify its regulatory compliance for use in my facility?

  The manufacturer, Neuro Navigational Corp., is based in Costa Mesa, California (92626). This device holds FDA 510(k) clearance (K961173), meaning it has been deemed substantially equivalent to a predicate device under 21 CFR 882.1480 (Class II). To verify compliance, check the FDA’s OpenFDA database using the registration number (3006546082) or product code (GWG). Always ensure your facility adheres to the manufacturer’s instructions and local regulatory requirements for neurological endoscopes.

• What types of procedures is this endoscope commonly used for, and what settings would be appropriate for its deployment?

  The 1.2mm NeuroView Endoscope is designed for high-resolution visualization in minimally invasive neurosurgical or interventional neuroradiology procedures, such as biopsies, tumor resections, or vascular interventions. It is intended for use in controlled clinical settings, such as operating rooms or neurointervention labs, where sterile conditions and specialized equipment are available. Its rigid, reusable design makes it suitable for procedures requiring precise, repeated imaging without the limitations of disposable alternatives.