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FDA 510(k)

Endo Ultrasonic Activator

K-Number: K222096 · 2023-03-23

Decision Date2023-03-23
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Endo Ultrasonic Activator is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K222096. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endo Ultrasonic Activator?

Endo Ultrasonic Activator is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K222096.

When did Endo Ultrasonic Activator receive FDA 510(k) clearance?

Endo Ultrasonic Activator received FDA 510(k) clearance on 2023-03-23, under 510(k) number K222096.

Who is the listed applicant for Endo Ultrasonic Activator?

The FDA 510(k) record lists Foshan Coxo Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endo Ultrasonic Activator?

The FDA product code for Endo Ultrasonic Activator is ELC.

Other records listing Foshan Coxo Medical Instrument 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: ELC)

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.