Nalu Neurostimulation System— 510(k) K183047

Clearance details

Applicant

Boston Scientific Neuromodulation

Product code

Code GZB

Device class

Class 2

Regulation

21 CFR 882.5880

Advisory panel

Neurology

Date received

2018-11-02

Decision date

2019-03-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Valencia, CA, US

• K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation2024-08-23
• K221376 — Nalu Neurostimulation System2022-06-10
• K203547 — Nalu Neurostimulation System2021-03-25
• K202274 — Nalu 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 kits2020-11-09
• K201618 — Nalu Neurostimulation SCS system2020-07-15

• K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation2024-08-21
• K190960 — Nalu Lead Blank (50cm)2019-07-11
• K183579 — Nalu 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 kits2019-03-29

Death

4

Injury

1,879

Other

2

Total

1,885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2257-2024 — Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.Class II·Ongoing·Nalu Medical, Inc.·20240603

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183047.