MiniStim MS-IVB Peripheral Nerve Stimulator— 510(k) K143095

Substantially Equivalent

Halyard Health, Inc.

FDA 510(k) clearance K143095 for MiniStim MS-IVB Peripheral Nerve Stimulator, Substantially Equivalent on 2015-03-24. Applicant: Halyard Health, Inc..

Clearance details

Applicant: Halyard Health, Inc.
Product code: Code BXN
Advisory panel: Anesthesiology
Date received: 2014-10-28
Decision date: 2015-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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.