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FDA 510(k)

Microwave Ablation System

K-Number: K183153 · 2019-07-08

ApplicantSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Decision Date2019-07-08
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Microwave Ablation System is a medical device manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2019-07-08 under approval number K183153. 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 Microwave Ablation System?

Microwave Ablation System is a medical device that received FDA 510(k) clearance on 2019-07-08. It is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K183153.

When was Microwave Ablation System approved by the FDA?

Microwave Ablation System received FDA 510(k) clearance on 2019-07-08, under approval number K183153.

What company makes Microwave Ablation System?

Microwave Ablation System is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd..

What is the FDA product code for Microwave Ablation System?

The FDA product code for Microwave Ablation System is NEY.

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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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