Home / 510(k) Clearances / K033173

510(k) K033173

MICRO TARGETING ELECTRODE by FHC, Inc. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2004
Date Received
October 1, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

Other clearances by FHC, Inc.

  • K231141 — STarFix Designer Software C0265 (September 8, 2023)
  • K200169 — VFS1 Bipolar Electrosurgical Generator (May 14, 2020)
  • K183123 — microTargeting Guideline 4000 5.0 System (December 20, 2018)
  • K121950 — MICROTARGETING XL STAR DRIVE SYSTEM (July 26, 2012)
  • K092192 — WAYPOINT STEREOTACTIC SYSTEM (February 12, 2010)
  • K092562 — MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS (September 18, 2009)
  • K071364 — MICROTARGETING GUIDELINE 4000 (July 25, 2007)
  • K011775 — MICRO TARGETING DRIVE SYSTEM (August 30, 2001)
  • K011992 — FHC MICROTARGETING DRIVE SYSTEM (August 14, 2001)
  • K003776 — MICROTARGETING DRIVE SYSTEM (February 23, 2001)

Other clearances for product code GZL

  • K250363 — Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12 (November 5, 2025)
  • K250601 — Neuro Omega System; NeuroSmart System (March 30, 2025)
  • K223269 — Spencer Probe Depth Electrodes (May 18, 2023)
  • K223276 — Anchor Bolts as Accessories to Depth Electrodes (May 18, 2023)
  • K213170 — SENSOSEEG Depth Electrodes (April 18, 2023)
  • K222706 — iCE-SG2 Subcutaneous Electrode Kit (December 6, 2022)
  • K222404 — Evo® sEEG System (October 20, 2022)
  • K220553 — Neuro Omega System, NeuroSmart System (September 16, 2022)
  • K202087 — DIXI Medical Microdeep Micro-Macro Depth Electrodes (November 18, 2021)
  • K211367 — Evo sEEG System (September 1, 2021)