Home / 510(k) Clearances / K020955

510(k) K020955

NICOLET ELECTROCAUTERY DETECTOR by Nicolet Biomedical, Inc. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2002
Date Received
March 25, 2002
Clearance Type
Abbreviated
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 Nicolet Biomedical, Inc.

  • K020754 — NICOLET PIONEER TC8080 (April 21, 2003)
  • K021986 — BRAINET (August 23, 2002)
  • K021144 — SUBDURAL STRIP ELECTRODE (June 24, 2002)
  • K020218 — SNAP EEG MONITOR (April 22, 2002)
  • K013281 — VERSALAB APM (April 18, 2002)
  • K013419 — NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM (December 20, 2001)
  • K011818 — STERILE EMG ELECTRODES (September 6, 2001)
  • K011823 — BIOREHAB SYSTEM (September 6, 2001)
  • K011135 — GSI AUDERA (July 26, 2001)
  • K010019 — STERILE SUBDERMAL NEEDLE ELECTRODES (March 19, 2001)

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)