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510(k) K961013

DISPOSABLE NEEDLE ELECTRODE by Medelec Intl. Corp. — Product Code IKT

K961013 is an FDA 510(k) premarket notification submitted by Medelec Intl. Corp. for the device "DISPOSABLE NEEDLE ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 20, 1996. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Medelec Intl. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1996
Date Received
March 13, 1996
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 Medelec Intl. Corp.

  • K935017 — TD50 ELECTROMYOGRAPH (July 28, 1994)
  • K922548 — MEDELEC 2110 AND 2114 EEG (November 3, 1992)
  • K920127 — ELECTROENCEPHALOGRAPH RECORDING SYSTEM (June 10, 1992)
  • K912775 — SAPPHIRE 4ME EMG/EP SYSTEM (November 8, 1991)
  • K865106 — PROPHYLACTIC (CONDOM) MR. JOHNNY (May 20, 1987)
  • K863491 — BLOOD SPECIMEN COLLECTION DEVICES (October 24, 1986)
  • K854622 — PROPHYLACTIC (CONDOM) (April 11, 1986)
  • K854562 — CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I (January 9, 1986)
  • K854858 — SCALPEL HANDLE (December 24, 1985)
  • K854857 — SCALPEL, ONE-PIECE, DISPOSABLE (December 24, 1985)

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