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510(k) K233801

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation by Boston Scientific Neuromodulation — Product Code GZB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 23, 2024
Date Received: November 29, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device Class: Class II
Regulation Number: 882.5880
Review Panel: NE
Submission Type

Other clearances by Boston Scientific Neuromodulation

K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation (August 21, 2024)
K221376 — Nalu Neurostimulation System (June 10, 2022)
K203547 — Nalu Neurostimulation System (March 25, 2021)
K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimula (November 9, 2020)
K201618 — Nalu Neurostimulation SCS system (July 15, 2020)
K190960 — Nalu Lead Blank (50cm) (July 11, 2019)
K183579 — Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimul (March 29, 2019)
K183047 — Nalu Neurostimulation System (March 22, 2019)

Other clearances for product code GZB

K221376 — Nalu Neurostimulation System (June 10, 2022)
K203547 — Nalu Neurostimulation System (March 25, 2021)
K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimula (November 9, 2020)
K201618 — Nalu Neurostimulation SCS system (July 15, 2020)
K191466 — SandShark Injectable Anchor (SIA) System (November 7, 2019)
K190960 — Nalu Lead Blank (50cm) (July 11, 2019)
K182720 — Freedom Spinal Cord Stimulator (SCS) System (March 29, 2019)
K183047 — Nalu Neurostimulation System (March 22, 2019)
K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (September 19, 2018)
K172644 — Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, (November 3, 2017)