FDA 510(k)

Nitinol Thermocouple (TCN) Electrode

K-Number: K183177 · 2019-03-08

Decision Date2019-03-08

Product CodeGXI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Nitinol Thermocouple (TCN) Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-03-08 under 510(k) number K183177. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nitinol Thermocouple (TCN) Electrode?

Nitinol Thermocouple (TCN) Electrode is a medical device that received FDA 510(k) clearance on 2019-03-08. The listed applicant is Boston Scientific Corporation. The 510(k) number is K183177.

When did Nitinol Thermocouple (TCN) Electrode receive FDA 510(k) clearance?

Nitinol Thermocouple (TCN) Electrode received FDA 510(k) clearance on 2019-03-08, under 510(k) number K183177.

Who is the listed applicant for Nitinol Thermocouple (TCN) Electrode?

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

What is the FDA product code for Nitinol Thermocouple (TCN) Electrode?

The FDA product code for Nitinol Thermocouple (TCN) Electrode is GXI.

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.

NCT01385176Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)ACTIVE_NOT_RECRUITING NCT01550575Patient Retrospective Outcomes (PRO)RECRUITING NCT01719055RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainRECRUITING NCT02071134Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryRECRUITING NCT02686125Vercise™ DBS Dystonia Prospective StudyRECRUITING NCT02928497Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral AnticoagulationTERMINATED

Other records listing Boston Scientific Corporation as applicant

K262406EluPro Antibiotic-Eluting BioEnvelope PMA P150031Stimulator, electrical, implanted, for parkinsonian symptoms PMA P030017Stimulator, spinal-cord, totally implanted for pain relief PMA P190006Implanted electrical device intended for treatment of fecal incontinence PMA P180046Stimulator, electrical, implantable, for incontinence PMA P180011Stent, superficial femoral artery, drug-eluting

View all 251 devices →

Related Devices (Code: GXI)

K253907Disposable Radiofrequency CannulaABBOTT MEDICAL K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICAL K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments K241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

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.