Home / 510(k) Clearances / K152769

510(k) K152769

FREMAP ELECTRODE by Ad-Tech Medical Instrument Corporation — Product Code ETN

K152769 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corporation for the device "FREMAP ELECTRODE". The FDA issued a decision of Substantially Equivalent on May 6, 2016. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Ad-Tech Medical Instrument Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2016
Date Received
September 25, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

Other clearances by Ad-Tech Medical Instrument Corporation

  • K223276 — Anchor Bolts as Accessories to Depth Electrodes (May 18, 2023)
  • 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)
  • K152547 — DNAP Electrode (March 4, 2016)

Other clearances for product code ETN

  • K253536 — Evala Nerve Stimulator (EPNR002) (February 27, 2026)
  • K251672 — NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tu (February 10, 2026)
  • K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM (June 13, 2025)
  • K233001 — Bioscope Neuromonitor Device (December 13, 2024)
  • K241917 — EARP Nerve Cuff Electrode (July 31, 2024)
  • K232888 — Disposable Laryngeal Electrodes (December 21, 2023)
  • K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotrache (October 26, 2023)
  • K230853 — EARP Nerve Cuff Electrode (October 6, 2023)
  • K231580 — NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (August 30, 2023)
  • K223254 — C2 Xplore (January 27, 2023)

FDA data resources