Home / 510(k) Clearances / K253581

510(k) K253581

Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) by Technomed Europe — Product Code IKT

K253581 is an FDA 510(k) premarket notification submitted by Technomed Europe for the device "Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)". The FDA issued a decision of Substantially Equivalent on March 15, 2026. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Technomed Europe has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2026
Date Received
November 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

Other clearances by Technomed Europe

  • K254183 — MR Conditional Cup Electrodes (May 7, 2026)
  • K241045 — Disposable Subdermal Needle Electrode, Corkscrew (December 11, 2024)
  • 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)
  • K072016 — CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER C (October 19, 2007)
  • 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)

Other clearances for product code IKT

  • K173815 — Allergan Botox Needle Electrode (June 29, 2018)
  • K161430 — Myoject Luer Lock Needle Electrode (March 2, 2017)
  • K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, (June 3, 2016)
  • K143433 — Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable C (August 28, 2015)
  • K120342 — EMG RECORDING ELECTRODE ASSEMBLY (June 22, 2012)
  • K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (August 12, 2011)
  • K111131 — TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (June 17, 2011)
  • K092973 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR N (October 7, 2010)
  • K093825 — AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE (January 13, 2010)
  • K091410 — DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, (August 11, 2009)

FDA data resources