Home / 510(k) Clearances / K192606

510(k) K192606

SAC2 - Electrode Cream by Spes Medica Srl — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2020
Date Received
September 20, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Spes Medica Srl

  • K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi- (November 10, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K192603 — Spes Medica Subdermal Needle Electrodes (November 22, 2019)
  • K190050 — Tech Dots - Adhesive and conductive gel (July 19, 2019)
  • K133348 — STIM PROBE (November 21, 2014)
  • K120494 — DISPOSABLE ADHESIVE SURFACE ELECTRODE (June 11, 2012)
  • K093373 — LARYNGEAL SURFACE ELECTRODE (August 24, 2010)
  • K091410 — DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, (August 11, 2009)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K190050 — Tech Dots - Adhesive and conductive gel (July 19, 2019)