FDA.report

510(k) K232415

Device
Nalu Neurostimulation System for Peripheral Nerve Stimulation
Applicant
Boston Scientific Neuromodulation
510(k) number
K232415
Product code
GZF
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-21
Date received
2023-08-11
Regulation
882.5870
Classification name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Kaoru Lee Adair
Address
25155 Rye Canyon Loop Valencia CA US 91355 91355

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code GZF

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K000852RENEW NEUROSTIMULATION SYSTEMAdvanced Neuromodulation Systems2001-01-19