Modified MRL Neuroprobe System V

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

510(k) Number

K884869 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medical Research Laboratories, Inc. →

• What types of clinical procedures is the Modified MRL Neuroprobe System V designed to support within neurology?

  The Modified MRL Neuroprobe System V is specifically designed for neurological applications requiring targeted electrical stimulation of neural tissues. This includes procedures where precise neural modulation is critical, such as diagnostic assessments or therapeutic interventions in neurology. Its FDA clearance under product code GZJ reflects its intended use in clinical settings where controlled neural stimulation is essential.

• Is the Modified MRL Neuroprobe System V intended for single-use or reusable applications, and how does this affect its maintenance?

  The device is explicitly labeled as a reusable medical device, meaning it is engineered for repeated use in clinical settings. As a reusable system, proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and functionality between procedures. The FDA’s 510(k) clearance under a traditional review pathway confirms its design adheres to regulatory standards for reusable medical devices.

• What was the regulatory pathway and decision process for the FDA clearance of this device, and what does ‘substantially equivalent’ mean in this context?

  The Modified MRL Neuroprobe System V received FDA clearance via a traditional 510(k) review pathway, meaning the manufacturer demonstrated it was substantially equivalent to a legally marketed predicate device. The decision code SESE (Substantially Equivalent – Same Essential Features) confirms the device’s safety and effectiveness were compared to an existing standard. The Neurology (NE) Advisory Committee reviewed the submission before clearance on June 6, 1989, ensuring alignment with FDA guidelines for neurological stimulation devices.

• How do I verify the authenticity or compliance of this device with FDA standards?

  To confirm authenticity and compliance, check the device’s K-number (K884869) and ensure it matches the Modified MRL Neuroprobe System V listed under the FDA’s 510(k) database. The system was cleared under product code GZJ for neurological applications, and its traditional review pathway ensures adherence to FDA regulations. For further verification, contact the manufacturer at Medical Research Laboratories, Inc. (address: 6457 W. Howard St., Niles, IL 60648) or refer to the FDA’s public database.