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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 the device name listed in this FDA 510(k) record. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2021-10-25 under 510(k) 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. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K210488.

When did Ultrasonic Surgical & Electrosurgical Generator receive FDA 510(k) clearance?

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

Who is the listed applicant for Ultrasonic Surgical & Electrosurgical Generator?

The FDA 510(k) record lists Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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