Cleared Traditional

K982902 - PERIPHERAL NERVE STIMULATION (FDA 510(k) Clearance)

K982902 · Medtronic Vascular · Neurology device

Nov 1998

Decision

88d

Days

Class 2

Risk

K982902 is an FDA 510(k) clearance for the PERIPHERAL NERVE STIMULATION. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II - Special Controls, product code GZF).

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 10, 1998, 88 days after receiving the submission on August 14, 1998.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.

Submission Details

510(k) Number	K982902 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 14, 1998
Decision Date	November 10, 1998
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement

Device Classification

Product Code	GZF — Stimulator, Peripheral Nerve, Implanted (pain Relief)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 882.5870