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FDA 510(k)

Certus 140 2.45GHz Ablation System

K-Number: K173756 · 2018-10-24

ApplicantNeuwave Medical, Inc.
Decision Date2018-10-24
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Certus 140 2.45GHz Ablation System is a medical device manufactured by Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2018-10-24 under approval number K173756. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Certus 140 2.45GHz Ablation System?

Certus 140 2.45GHz Ablation System is a medical device that received FDA 510(k) clearance on 2018-10-24. It is manufactured by Neuwave Medical, Inc.. The 510(k) number is K173756.

When was Certus 140 2.45GHz Ablation System approved by the FDA?

Certus 140 2.45GHz Ablation System received FDA 510(k) clearance on 2018-10-24, under approval number K173756.

What company makes Certus 140 2.45GHz Ablation System?

Certus 140 2.45GHz Ablation System is manufactured by Neuwave Medical, Inc..

What is the FDA product code for Certus 140 2.45GHz Ablation System?

The FDA product code for Certus 140 2.45GHz Ablation System is NEY.

Related Clinical Trials

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Related PubMed Literature

PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

Other Devices by Neuwave Medical, Inc.

K161285Ablation Confirmation K160936Certus 140 2.45GHz Ablation System K171022Ablation Confirmation K163118FLEX Microwave Ablation System and Accessories K192427Ablation Confirmation K200081NEUWAVE Microwave Ablation System and Accessories

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Related Devices (Code: NEY)

K163105Emprint Ablation SystemCovidien, LLC K160141miraDry SystemMiramar Labs, Inc. K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, 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.

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