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510(k) K053250

ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT by Advanced Neuromodulation Systems — Product Code GZB

K053250 is an FDA 510(k) premarket notification submitted by Advanced Neuromodulation Systems for the device "ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT". The FDA issued a decision of Substantially Equivalent on December 15, 2005. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Advanced Neuromodulation Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2005
Date Received
November 21, 2005
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 Advanced Neuromodulation Systems

  • K092371 — SWIFT-LOCK ANCHOR, MODEL 1192 (December 23, 2009)
  • 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)
  • K052374 — RAPID PROGEAMMER 3.0 (November 22, 2005)
  • K052418 — AXXESS BUTTERFLY ANCHOR (September 26, 2005)
  • K050922 — ANS SCS ACCESSORY KIT (May 18, 2005)
  • K050633 — TRIAL CABLE RETENTION CLIP (April 21, 2005)

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)
  • 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)

FDA data resources