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510(k) K000852

RENEW NEUROSTIMULATION SYSTEM by Advanced Neuromodulation Systems — Product Code GZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2001
Date Received
March 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5870
Review Panel
NE
Submission Type

Other clearances by Advanced Neuromodulation Systems

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  • K090907 — PENTA LEAD KITS, MODELS: 3227-3234 (June 2, 2009)
  • K081208 — CINCH ANCHOR, MODEL 1194 (July 18, 2008)
  • K072462 — WIDE SPACED QUATTRODE LEADS (October 11, 2007)
  • K070847 — TRIAL CABLE, 3009 (April 11, 2007)
  • K063080 — TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS (December 12, 2006)
  • K053250 — ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT (December 15, 2005)
  • K052374 — RAPID PROGEAMMER 3.0 (November 22, 2005)
  • K052418 — AXXESS BUTTERFLY ANCHOR (September 26, 2005)
  • K050922 — ANS SCS ACCESSORY KIT (May 18, 2005)

Other clearances for product code GZF

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  • K243678 — TalisMann Neuromodulation System (July 3, 2025)
  • K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation (August 21, 2024)
  • K233162 — Freedom Peripheral Nerve Stimulator (PNS) System (June 20, 2024)
  • K221303 — Neuspera Nuity System (April 11, 2023)
  • K211965 — StimRouter Neuromodulation System (February 23, 2022)
  • K202781 — Neuspera Neurostimulation System (NNS) (August 27, 2021)
  • K200848 — Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit (August 14, 2020)
  • K200482 — StimRouter Neuromodulation System (March 27, 2020)
  • K190047 — StimRouter Neuromodulation System (October 31, 2019)