STIMTRODE SINGLE USE NERVE STIMULATOR— 510(k) K110118

Substantially Equivalent

Xavant Technology (Pty), Ltd.

FDA 510(k) clearance K110118 for STIMTRODE SINGLE USE NERVE STIMULATOR, Substantially Equivalent on 2011-02-17. Applicant: Xavant Technology (Pty), Ltd..

Clearance details

Applicant: Xavant Technology (Pty), Ltd.
Product code: Code BXN
Advisory panel: Anesthesiology
Date received: 2011-01-18
Decision date: 2011-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Pretoria, Gauteng, ZA

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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.