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510(k) K182720

Freedom Spinal Cord Stimulator (SCS) System by Stimwave Technologies Incorporated — Product Code GZB

K182720 is an FDA 510(k) premarket notification submitted by Stimwave Technologies Incorporated for the device "Freedom Spinal Cord Stimulator (SCS) System". The FDA issued a decision of Substantially Equivalent on March 29, 2019. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Stimwave Technologies Incorporated has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2019
Date Received
September 28, 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

  • 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)
  • 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

  • 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)
  • 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)
  • 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)

FDA data resources