Cleared Traditional

MiniStim MS-IVB Peripheral Nerve Stimulator

K143095 · Halyard Health, Inc. · Anesthesiology
Mar 2015
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K143095 is an FDA 510(k) clearance for the MiniStim MS-IVB Peripheral Nerve Stimulator, a Stimulator, Nerve, Battery-powered (Class II — Special Controls, product code BXN), submitted by Halyard Health, Inc. (Roswell, US). The FDA issued a Cleared decision on March 24, 2015, 147 days after receiving the submission on October 28, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number K143095 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2014
Decision Date March 24, 2015
Days to Decision 147 days
Submission Type Traditional
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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