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FDA 510(k)

Radio Frequency Ablation System

K-Number: K190052 · 2019-06-25

ApplicantSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Decision Date2019-06-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Radio Frequency Ablation System is a medical device manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2019-06-25 under approval number K190052. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radio Frequency Ablation System?

Radio Frequency Ablation System is a medical device that received FDA 510(k) clearance on 2019-06-25. It is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K190052.

When was Radio Frequency Ablation System approved by the FDA?

Radio Frequency Ablation System received FDA 510(k) clearance on 2019-06-25, under approval number K190052.

What company makes Radio Frequency Ablation System?

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

What is the FDA product code for Radio Frequency Ablation System?

The FDA product code for Radio Frequency Ablation System is GEI.

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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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