Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ultrasonic Scalpel System

K-Number: K212614 · 2022-07-18

Decision Date2022-07-18
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Scalpel System 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 2022-07-18 under 510(k) 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. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K212614.

When did Ultrasonic Scalpel System receive FDA 510(k) clearance?

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

Who is the listed applicant for Ultrasonic Scalpel System?

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 Scalpel System?

The FDA product code for Ultrasonic Scalpel System is LFL.

Other records listing Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: LFL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.