Cleared Special

STIMPOD ST2-3010 NERVE STIMULATOR

K140853 · Xavant Technology (Pty), Ltd. · Anesthesiology
Nov 2014
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K140853 is an FDA 510(k) clearance for the STIMPOD ST2-3010 NERVE STIMULATOR, a Stimulator, Nerve, Battery-powered (Class II — Special Controls, product code BXN), submitted by Xavant Technology (Pty), Ltd. (Pretoria, Gauteng, ZA). The FDA issued a Cleared decision on November 6, 2014, 217 days after receiving the submission on April 3, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number K140853 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2014
Decision Date November 06, 2014
Days to Decision 217 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BXN — Stimulator, Nerve, Battery-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2775

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