Cleared Special

Nalu Neurostimulation System

K221376 · Boston Scientific Neuromodulation · Neurology
Jun 2022
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K221376 is an FDA 510(k) clearance for the Nalu Neurostimulation System, a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II — Special Controls, product code GZB), submitted by Boston Scientific Neuromodulation (Valencia, US). The FDA issued a Cleared decision on June 10, 2022, 29 days after receiving the submission on May 12, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5880.

Submission Details

510(k) Number K221376 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2022
Decision Date June 10, 2022
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZB — Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5880

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