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510(k) K112214

OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS by St. Jude Medical Neuromodulation — Product Code GZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2011
Date Received
August 2, 2011
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 St. Jude Medical Neuromodulation

  • K123299 — MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS (January 18, 2013)

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  • K201618 — Nalu Neurostimulation SCS system (July 15, 2020)
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  • 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)