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510(k) K223276

Anchor Bolts as Accessories to Depth Electrodes by Ad-Tech Medical Instrument Corporation — Product Code GZL

K223276 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corporation for the device "Anchor Bolts as Accessories to Depth Electrodes". The FDA issued a decision of Substantially Equivalent on May 18, 2023. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Ad-Tech Medical Instrument Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2023
Date Received
October 24, 2022
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 Corporation

  • K223269 — Spencer Probe Depth Electrodes (May 18, 2023)
  • K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid (January 25, 2020)
  • K181544 — Anchor Bolt (as an accessory to Depth Electrodes) (August 9, 2018)
  • K170442 — Cranial Drill Bits and Accessories (September 7, 2017)
  • K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, S (April 12, 2017)
  • K152769 — FREMAP ELECTRODE (May 6, 2016)
  • K152547 — DNAP Electrode (March 4, 2016)

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)
  • 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)

FDA data resources