Cleared Traditional

Nalu Lead Blank (50cm)

K190960 · Boston Scientific Neuromodulation · Neurology
Jul 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K190960 is an FDA 510(k) clearance for the Nalu Lead Blank (50cm), 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 July 11, 2019, 90 days after receiving the submission on April 12, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5880.

Submission Details

510(k) Number K190960 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2019
Decision Date July 11, 2019
Days to Decision 90 days
Submission Type Traditional
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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