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FDA 510(k)

Nalu Lead Blank (50cm)

K-Number: K190960 · 2019-07-11

ApplicantBoston Scientific Neuromodulation
Decision Date2019-07-11
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nalu Lead Blank (50cm) is a medical device manufactured by Boston Scientific Neuromodulation. It received FDA 510(k) clearance on 2019-07-11 under approval number K190960. 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 Lead Blank (50cm)?

Nalu Lead Blank (50cm) is a medical device that received FDA 510(k) clearance on 2019-07-11. It is manufactured by Boston Scientific Neuromodulation. The 510(k) number is K190960.

When was Nalu Lead Blank (50cm) approved by the FDA?

Nalu Lead Blank (50cm) received FDA 510(k) clearance on 2019-07-11, under approval number K190960.

What company makes Nalu Lead Blank (50cm)?

Nalu Lead Blank (50cm) is manufactured by Boston Scientific Neuromodulation.

What is the FDA product code for Nalu Lead Blank (50cm)?

The FDA product code for Nalu Lead Blank (50cm) is GZB.

Other Devices by Boston Scientific Neuromodulation

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 K203547Nalu Neurostimulation System K221376Nalu Neurostimulation System

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Related Devices (Code: GZB)

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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.

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