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510(k) K973454

AD-TECH'S SPINAL ELECTRODE by Ad-Tech Medical Instrument Corp — Product Code GZL

K973454 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corp for the device "AD-TECH'S SPINAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on June 10, 1998. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Ad-Tech Medical Instrument Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1998
Date Received
September 11, 1997
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 Ad-Tech Medical Instrument Corp

  • K112094 — BRAIN BIOPSY NEEDLE (April 24, 2012)
  • K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRA (May 30, 2006)
  • K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTROD (May 25, 2006)
  • K041604 — MACRO-MICRO DEPTH ELECTRODE (August 16, 2004)
  • K990788 — AD-TECH'S FORAMEN OVALE ELECTRODE (November 2, 1999)
  • K992194 — CORTICAL MAPPING UNIT, MODEL CMU (September 13, 1999)
  • K970587 — AD-TECH SUBDURAL ELECTRODE (May 9, 1997)
  • K964644 — AD-TECH'S DEPTH ELECTRODE (May 9, 1997)
  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • K944061 — CUEVA CRANIAL NERVE ELECTRODE (January 20, 1995)

Other clearances for product code GZL

  • K253970 — Wovyn Depth Electrode (April 17, 2026)
  • 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)

FDA data resources