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FDA 510(k)

TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES

K-Number: K973442 · 1997-11-20

ApplicantMedelec, Inc. D.B.A. Teca Corp.
Decision Date1997-11-20
Product CodeIKT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Medelec, Inc. D.B.A. Teca Corp.. It received FDA 510(k) clearance on 1997-11-20 under 510(k) number K973442. 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 TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES?

TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES is a medical device that received FDA 510(k) clearance on 1997-11-20. The listed applicant is Medelec, Inc. D.B.A. Teca Corp.. The 510(k) number is K973442.

When did TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES receive FDA 510(k) clearance?

TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES received FDA 510(k) clearance on 1997-11-20, under 510(k) number K973442.

Who is the listed applicant for TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES?

The FDA 510(k) record lists Medelec, Inc. D.B.A. Teca Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES?

The FDA product code for TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES is IKT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medelec, Inc. D.B.A. Teca Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971914TECA NCS ELECTRODE SYSTEM 2000K973444TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES

Related Devices (Code: IKT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 EuropeK173815Allergan Botox Needle ElectrodeNatus Manufacturing LimitedK161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing LimitedK152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLCK112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, Inc.

Official Source

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

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