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Neuromed Octrode Model Mnr-88B/88C Neurostim Syst

by Neuromed, Inc.

510(k) K905596

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905596 Date11 Mar 1991ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GZB
Device Class
Class II
Regulation
21 CFR Part 882.5880
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Neuromed Octrode Model MNR-88B/88C Neurostim System is an implanted spinal cord stimulator device used for pain relief. It is classified as a neurostimulation system designed to deliver electrical stimulation to the spinal cord.

The device is supplied by Neuromed, Inc. and has received FDA 510(k) clearance with K number K905596. It is a class II device regulated under product code GZB. The system is intended for implantation and use in neurology applications.

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