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510(k) K180981

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit by Stimwave Technologies Incorporated — Product Code GZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2018
Date Received
April 13, 2018
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 Stimwave Technologies Incorporated

  • K182720 — Freedom Spinal Cord Stimulator (SCS) System (March 29, 2019)
  • K172644 — Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, (November 3, 2017)
  • K170141 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna (May 2, 2017)
  • K162161 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna (December 16, 2016)
  • K160600 — Freedom Spinal Cord Stimulator System (August 26, 2016)
  • K150517 — Freedom Spinal Cord Stimulator System (June 5, 2015)
  • K141399 — FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM (October 10, 2014)

Other clearances for product code GZB

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  • 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)
  • K172644 — Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, (November 3, 2017)