Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Nalu Neurostimulation System

K-Number: K203547 · 2021-03-25

ApplicantBoston Scientific Neuromodulation
Decision Date2021-03-25
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nalu Neurostimulation System is a medical device manufactured by Boston Scientific Neuromodulation. It received FDA 510(k) clearance on 2021-03-25 under approval number K203547. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nalu Neurostimulation System?

Nalu Neurostimulation System is a medical device that received FDA 510(k) clearance on 2021-03-25. It is manufactured by Boston Scientific Neuromodulation. The 510(k) number is K203547.

When was Nalu Neurostimulation System approved by the FDA?

Nalu Neurostimulation System received FDA 510(k) clearance on 2021-03-25, under approval number K203547.

What company makes Nalu Neurostimulation System?

Nalu Neurostimulation System is manufactured by Boston Scientific Neuromodulation.

What is the FDA product code for Nalu Neurostimulation System?

The FDA product code for Nalu Neurostimulation System is GZB.

Related Clinical Trials

NCT07301346 EASEE® System Pivotal Study for the United States of America NOT_YET_RECRUITING NCT05343988 Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children TERMINATED NCT06782360 Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation COMPLETED

Other Devices by Boston Scientific Neuromodulation

K190960Nalu Lead Blank (50cm) K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits K183047Nalu Neurostimulation System K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits K201618Nalu Neurostimulation SCS system K221376Nalu Neurostimulation System

View all 10 devices →

Related Devices (Code: GZB)

K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseStimwave Technologies Incorporated K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitStimwave Technologies Incorporated K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑