Cleared Traditional

STIM PROBE

K133348 · Spes Medica Srl · Ear, Nose, Throat
Nov 2014
Decision
387d
Days
Class 2
Risk

About This 510(k) Submission

K133348 is an FDA 510(k) clearance for the STIM PROBE, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on November 21, 2014, 387 days after receiving the submission on October 30, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K133348 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2013
Decision Date November 21, 2014
Days to Decision 387 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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