Cleared Traditional

TELIGEN System Peripheral Motor Nerve Stimulation Indications

K223438 · Medos International SARL · Neurology

Feb 2023

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K223438 is an FDA 510(k) clearance for the TELIGEN System Peripheral Motor Nerve Stimulation Indications, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on February 10, 2023, 88 days after receiving the submission on November 14, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K223438 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2022
Decision Date	February 10, 2023
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PDQ — Neurosurgical Nerve Locator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.1820
Definition	To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.