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510(k) K201618

Nalu Neurostimulation SCS system by Boston Scientific Neuromodulation — Product Code GZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2020
Date Received
June 15, 2020
Clearance Type
Special
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

  • K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation (August 23, 2024)
  • 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)
  • 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

  • K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation (August 23, 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)
  • 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)