FDA 510(k)

ELECTRODE NEEDLES

K-Number: K990015 · 1999-05-27

Decision Date1999-05-27

Product CodeIKT

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

ELECTRODE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Technomed Europe. It received FDA 510(k) clearance on 1999-05-27 under 510(k) number K990015. The device is classified under product code IKT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRODE NEEDLES?

ELECTRODE NEEDLES is a medical device that received FDA 510(k) clearance on 1999-05-27. The listed applicant is Technomed Europe. The 510(k) number is K990015.

When did ELECTRODE NEEDLES receive FDA 510(k) clearance?

ELECTRODE NEEDLES received FDA 510(k) clearance on 1999-05-27, under 510(k) number K990015.

Who is the listed applicant for ELECTRODE NEEDLES?

The FDA 510(k) record lists Technomed Europe as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRODE NEEDLES?

The FDA product code for ELECTRODE NEEDLES is IKT.

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Other records listing Technomed Europe as applicant

K254183MR Conditional Cup Electrodes K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)K241045Disposable Subdermal Needle Electrode, Corkscrew K130136DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,K121257LARYNGEAL ELECTRODE K110422SURGICAL STIMULATORS

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Related Devices (Code: IKT)

K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)Technomed Europe K173815Allergan Botox Needle ElectrodeNatus Manufacturing Limited K161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing Limited K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLC K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.