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510(k) K072016

CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE by Technomed Europe — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2007
Date Received
July 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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  • K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUB (July 19, 2013)
  • K121257 — LARYNGEAL ELECTRODE (August 28, 2012)
  • K110422 — SURGICAL STIMULATORS (May 26, 2011)
  • K073532 — DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES (May 1, 2008)
  • K063729 — DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 (August 21, 2007)
  • K062437 — DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE (February 16, 2007)
  • K050325 — DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROB (May 5, 2005)
  • K042375 — SMK, CX, CXE, RCN (October 26, 2004)

Other clearances for product code GXY

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  • K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (October 31, 2025)
  • K250841 — Electrotherapy Electrodes (August 13, 2025)
  • K243788 — IceCap product line (March 13, 2025)
  • K243243 — Delphi MCS Electrode Cap (February 6, 2025)
  • K241512 — Electrode Pad (January 15, 2025)
  • K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50) (January 2, 2025)
  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
  • K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (November 25, 2024)