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FDA 510(k)

Ultrasonic Scalpel System

K-Number: K212614 · 2022-07-18

ApplicantSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Decision Date2022-07-18
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Scalpel System is a medical device manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2022-07-18 under approval number K212614. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasonic Scalpel System?

Ultrasonic Scalpel System is a medical device that received FDA 510(k) clearance on 2022-07-18. It is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K212614.

When was Ultrasonic Scalpel System approved by the FDA?

Ultrasonic Scalpel System received FDA 510(k) clearance on 2022-07-18, under approval number K212614.

What company makes Ultrasonic Scalpel System?

Ultrasonic Scalpel System is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd..

What is the FDA product code for Ultrasonic Scalpel System?

The FDA product code for Ultrasonic Scalpel System is LFL.

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Other Devices by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

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Related Devices (Code: LFL)

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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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