Dantec Disposable Concentric Needle

Q: What is the product code of K931966?

The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.

FDA 510(k) K931966 · Dantec Medical, Inc.

Substantially Equivalent

510(k) numberK931966

Submission

Device name: Dantec Disposable Concentric Needle
Applicant: Dantec Medical, Inc.
Washington, DC, US
Received: April 21, 1993
Decision date: March 30, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IKT – Electrode, Needle, Diagnostic Electromyograph
Device class: Class II (moderate risk)
Regulation: 21 CFR 890.1385
Specialty: Physical Medicine

Other 510(k)s with product code IKT

510(k)	Device	Applicant	Decision
K253581	Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional	Technomed Europe	03/15/2026SE
K173815	Allergan Botox Needle ElectrodeIKT · Traditional	Natus Manufacturing Limited	06/29/2018SE
K161430	Myoject Luer Lock Needle ElectrodeIKT · Traditional	Natus Manufacturing Limited	03/02/2017SE
K152984	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…IKT · Traditional	Bio Protech, Inc.	06/03/2016SE
K143433	Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…IKT · Traditional	Natus Manufacturing Limited	08/28/2015SE
K120342	Emg Recording Electrode AssemblyIKT · Traditional	Rhythmlink International, LLC	06/22/2012SE
K112034	Teca Elite Disposable Concentric NeedlesIKT · Special	Carefusion 209, Inc.	08/12/2011SE
K111131	Teca (TM) Elite Disposable Monopolar NeedlesIKT · Special	Carefusion 209, Inc.	06/17/2011SE
K092973	Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleIKT · Traditional	Bionen S.A.S.	10/07/2010SE
K093825	Ambu Neuroline Disposable Inoject Needle ElectrodeIKT · Special	Ambu A/S	01/13/2010SE

More from Ambu A/S

510(k)	Device	Decision
K960503	Dantec DuetFEN · Traditional	09/16/1996SE
K950314	Dantec Monopolar Lumen Electrode (13R18 and 13R19)GXZ · Traditional	03/25/1996SE
K953999	Dantec Da CapoEXY · Traditional	11/21/1995SE
K926363	Multi-Dop SIYO · Traditional	06/19/1995SE
K931801	Multi-Dop XIYO · Traditional	06/14/1995SE
K930458	Multi-Dop LIYN · Traditional	02/03/1995SE
K932059	Needle Electrodes and Disposable Scalp ElectrodeIKT · Traditional	10/04/1994SE
K934580	Dantec 13R45 Bar ElectrodeGXY · Traditional	09/26/1994SE
K931923	Dantec Maglite Magnetic Stimulator (Maglite)GWF · Traditional	11/09/1993SE
K926516	Dantec Magnetic Stimulator MagproGWF · Traditional	08/31/1993SE

Questions and answers

When was Dantec Disposable Concentric Needle cleared by the FDA?

Dantec Disposable Concentric Needle (K931966) received a 510(k) decision of Substantially Equivalent on March 30, 1994, 343 days after the submission was received.

What is the product code of K931966?

The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.