Cleared Traditional

K940416 - NEUROLOGICAL LEADS (PACKAGING MODIFICATION) (FDA 510(k) Clearance)

K940416 · Medtronic Vascular · Neurology device

Jul 1994

Decision

171d

Days

Class 2

Risk

K940416 is an FDA 510(k) clearance for the NEUROLOGICAL LEADS (PACKAGING MODIFICATION). This device is classified as a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II - Special Controls, product code GZB).

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 18, 1994, 171 days after receiving the submission on January 28, 1994.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.

Submission Details

510(k) Number	K940416 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 28, 1994
Decision Date	July 18, 1994
Days to Decision	171 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GZB — Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 882.5880