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510(k) K982950

FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 by Chalgren Enterprises, Inc. — Product Code IKT

K982950 is an FDA 510(k) premarket notification submitted by Chalgren Enterprises, Inc. for the device "FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550". The FDA issued a decision of Substantially Equivalent on June 22, 1999. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Chalgren Enterprises, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1999
Date Received
August 21, 1998
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 Chalgren Enterprises, Inc.

  • K960591 — RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-X (June 13, 1996)
  • K955335 — DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE (January 29, 1996)
  • K953361 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K953354 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K953356 — EMG RECORDING RING ELECTRODE (January 22, 1996)
  • K952690 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K952908 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K953887 — RE-USABLE CONCENTRIC NEEDLE (October 31, 1995)
  • K953886 — RE-USABLE MONOPOLAR NEEDLE (October 31, 1995)
  • K953220 — 32MM NICKEL PLATED DISC ELECTRODE (October 6, 1995)

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