Skip to content

High Profile Needle Electrode (N-Spyral HP)

by Neurotechnics, Inc. 510(k)

Active United States

510(k) K863136

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863136 Date4 Sep 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GXZ
Device Class
Class II
Regulation
21 CFR Part 882.1350
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The High Profile Needle Electrode (N-Spyral HP) is a Class II medical device used for electrophysiological procedures. It is designed to record electrical activity from neural tissue during diagnostic and therapeutic interventions in neurology.

This device is supplied as a single-use or reusable product depending on the specific model configuration. It is not MRI compatible and requires standard storage conditions. The device has FDA 510(k) clearance with K number K863136 and is classified under product code GXZ for neurology applications.

Other devices from Neurotechnics, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the N-Spyral HP High Profile Needle Electrode used for?

    The N-Spyral HP High Profile Needle Electrode is designed specifically for electrophysiological procedures in neurology. It records electrical activity from neural tissue during diagnostic and therapeutic interventions, helping clinicians monitor and analyze brain signals with precision.

  • Is the N-Spyral HP High Profile Needle Electrode single-use or reusable?

    The N-Spyral HP High Profile Needle Electrode can be supplied as either single-use or reusable, depending on the specific model configuration. This flexibility allows clinicians to choose based on their procedural needs, infection control protocols, and resource availability.

  • Can the N-Spyral HP High Profile Needle Electrode be used in MRI environments?

    No, the N-Spyral HP High Profile Needle Electrode is not MRI compatible. This means it should not be used in magnetic resonance imaging environments, as the device may interfere with MRI functionality or be damaged by the magnetic fields.

  • What storage conditions are required for the N-Spyral HP High Profile Needle Electrode?

    The device requires standard storage conditions, meaning it should be kept in a clean, dry environment protected from extreme temperatures, humidity, and direct sunlight. Proper storage ensures the integrity and functionality of the electrode for its intended use.

  • What is the FDA clearance status and product code for the N-Spyral HP High Profile Needle Electrode?

    The N-Spyral HP High Profile Needle Electrode holds FDA 510(k) clearance with the K number K863136. It is classified under product code GXZ for neurology applications, indicating its regulatory pathway and intended use within the field of neurology.