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510(k) K990375

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 by Medtronic Functional Diagnostics A/S — Product Code IKT

K990375 is an FDA 510(k) premarket notification submitted by Medtronic Functional Diagnostics A/S for the device "DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75". The FDA issued a decision of Substantially Equivalent on March 9, 1999. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Medtronic Functional Diagnostics A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1999
Date Received
February 8, 1999
Clearance Type
Special
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 Medtronic Functional Diagnostics A/S

  • K014269 — POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF (November 21, 2002)
  • K011471 — BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PRO (November 8, 2002)
  • K002992 — DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013 (August 15, 2001)
  • K011472 — POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOM (August 10, 2001)
  • K010130 — POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 (February 7, 2001)
  • K000386 — POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 (May 5, 2000)
  • K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E0101 (February 28, 2000)
  • K992713 — POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G (November 10, 1999)
  • K991389 — ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 (July 15, 1999)
  • K981733 — DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 (February 4, 1999)

Other clearances for product code IKT

  • K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable (March 15, 2026)
  • 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)

FDA data resources