K232415

Nalu Neurostimulation System for Peripheral Nerve Stimulation

510(k) number
K232415
Device name
Nalu Neurostimulation System for Peripheral Nerve Stimulation
Applicant
Boston Scientific Neuromodulation CA · US
Product code
GZF — Stimulator, Peripheral Nerve, Implanted (Pain Relief
Decision date
2024-08-21
Date received
2023-08-11
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K232415.pdf

Official FDA record: K232415
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.