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Low Profile Needle Electrode (N-Spyral LP

by Neurotechnics, Inc. 510(k)

Active United States

510(k) K863135

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863135 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  • Withdrawn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, 23 Sep 2026

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

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals. The Low Profile Needle Electrode (N-Spyral LP) is a neurology device designed for subcutaneous placement to either stimulate or record electrical activity.

It is supplied as a single-use device, with regulatory authorization under FDA 510(k) clearance K863135, classified as a Class II device under regulation number 882.1350. The device was cleared through the traditional pathway, with a decision date of September 4, 1987, and is intended for use in neurology settings.

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