Teca (TM) Elite Disposable Monopolar Needles

FDA 510(k) K111131 · Carefusion 209, Inc.

Substantially Equivalent

510(k) numberK111131

Submission

Device name
Teca (TM) Elite Disposable Monopolar Needles
Applicant
Carefusion 209, Inc.
Middleton, WI, US
Received
April 21, 2011
Decision date
June 17, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 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

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K173815Allergan Botox Needle ElectrodeIKT · Traditional Natus Manufacturing Limited06/29/2018SE
K161430Myoject Luer Lock Needle ElectrodeIKT · Traditional Natus Manufacturing Limited03/02/2017SE
K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…IKT · Traditional Bio Protech, Inc.06/03/2016SE
K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…IKT · Traditional Natus Manufacturing Limited08/28/2015SE
K120342Emg Recording Electrode AssemblyIKT · Traditional Rhythmlink International, LLC06/22/2012SE
K112034Teca Elite Disposable Concentric NeedlesIKT · Special Carefusion 209, Inc.08/12/2011SE
K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleIKT · Traditional Bionen S.A.S.10/07/2010SE
K093825Ambu Neuroline Disposable Inoject Needle ElectrodeIKT · Special Ambu A/S01/13/2010SE
K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,IKT · Traditional Spes Medica Srl08/11/2009SE

More from Spes Medica Srl

510(k)DeviceDecision
K120979Carefusion Nicolet EdxGWF · Special 04/25/2012SE
K112052Carefusion Nicolet EdxGWF · Traditional 03/15/2012SE
K112034Teca Elite Disposable Concentric NeedlesIKT · Special 08/12/2011SE
K103140Nicolet Wireless EEGGWL · Traditional 04/08/2011SE

Questions and answers

When was Teca (TM) Elite Disposable Monopolar Needles cleared by the FDA?

Teca (TM) Elite Disposable Monopolar Needles (K111131) received a 510(k) decision of Substantially Equivalent on June 17, 2011, 57 days after the submission was received.

What is the product code of K111131?

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