STIMPOD ST2-3010 NERVE STIMULATOR— 510(k) K140853

Name: FDA 510(k) clearance K140853
Creator: U.S. Food and Drug Administration
Published: 2014-11-06

Substantially Equivalent

Xavant Technology (Pty), Ltd.

FDA 510(k) clearance K140853 for STIMPOD ST2-3010 NERVE STIMULATOR, Substantially Equivalent on 2014-11-06. Applicant: Xavant Technology (Pty), Ltd.. Device class: 2.

Clearance details

Applicant: Xavant Technology (Pty), Ltd.
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 2014-04-03
Decision date: 2014-11-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Pretoria, Gauteng, ZA

Download summary PDF View on FDA.gov ↗

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K093591 — STIMPOD MODEL NMS-400 NERVE STIMULATOR2009-12-03
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Adverse events under product code BXN

product code BXN

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.