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FDA 510(k)

Ultrasonic Surgical & Electrosurgical Generator

K-Number: K210488 · 2021-10-25

ApplicantSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Decision Date2021-10-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Surgical & Electrosurgical Generator is a medical device manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2021-10-25 under approval number K210488. 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 Ultrasonic Surgical & Electrosurgical Generator?

Ultrasonic Surgical & Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2021-10-25. It is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K210488.

When was Ultrasonic Surgical & Electrosurgical Generator approved by the FDA?

Ultrasonic Surgical & Electrosurgical Generator received FDA 510(k) clearance on 2021-10-25, under approval number K210488.

What company makes Ultrasonic Surgical & Electrosurgical Generator?

Ultrasonic Surgical & Electrosurgical Generator is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd..

What is the FDA product code for Ultrasonic Surgical & Electrosurgical Generator?

The FDA product code for Ultrasonic Surgical & Electrosurgical Generator 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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