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FDA 510(k)

AveCure BT Microwave Ablation System

K-Number: K192406 · 2020-11-25

ApplicantMedwaves, Inc.
Decision Date2020-11-25
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AveCure BT Microwave Ablation System is a medical device manufactured by Medwaves, Inc.. It received FDA 510(k) clearance on 2020-11-25 under approval number K192406. 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 AveCure BT Microwave Ablation System?

AveCure BT Microwave Ablation System is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Medwaves, Inc.. The 510(k) number is K192406.

When was AveCure BT Microwave Ablation System approved by the FDA?

AveCure BT Microwave Ablation System received FDA 510(k) clearance on 2020-11-25, under approval number K192406.

What company makes AveCure BT Microwave Ablation System?

AveCure BT Microwave Ablation System is manufactured by Medwaves, Inc..

What is the FDA product code for AveCure BT Microwave Ablation System?

The FDA product code for AveCure BT Microwave Ablation System is NEY.

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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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