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Neuromed Octrode Model MNR-88 W/98 Adapter

by Neuromed, Inc.

510(k) K901499

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 NumberK901499 Date29 Jun 1990ClearedStatusActive

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  • Withdrawn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)

Full name
Neuromed Octrode Model Mnr-88 W/98 Adapter Neuro.
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, 6 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 Neuromed Octrode Model MNR-88 with 98 Adapter is an implanted spinal cord stimulator designed for pain relief. It functions as a medical device within the neurology specialty to provide therapeutic stimulation.

This device is identified by K-number K901499 and has received FDA 510(k) clearance. It is regulated under 21 CFR 882.5880 as a Class 2 medical device.

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