Name: Predicase
Price: 199 USD

K-number	K232415
Device name	Nalu Neurostimulation System for Peripheral Nerve Stimulation
Applicant	Boston Scientific Neuromodulation
Product code	GZF
Device class	Class II
Decision date	Aug 21, 2024
Decision	Substantially Equivalent
Regulation	882.5870

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Nalu Neurostimulation System for Peripheral Nerve Stimulation

Everything you need for a 510(k) submission. Nothing you don't.