Cleared Traditional

Spes Medica Subdermal Needle Electrodes

K192603 · Spes Medica Srl · Neurology
Nov 2019
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K192603 is an FDA 510(k) clearance for the Spes Medica Subdermal Needle Electrodes, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Spes Medica Srl (Battipaglia (Sa), IT). The FDA issued a Cleared decision on November 22, 2019, 63 days after receiving the submission on September 20, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number K192603 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2019
Decision Date November 22, 2019
Days to Decision 63 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXZ — Electrode, Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1350

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