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FDA 510(k)

Ultrasonic Surgical Aspirator System

K-Number: K202299 · 2021-05-21

ApplicantSmtp Technology Co., Ltd.
Decision Date2021-05-21
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Surgical Aspirator System is a medical device manufactured by Smtp Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-05-21 under approval number K202299. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasonic Surgical Aspirator System?

Ultrasonic Surgical Aspirator System is a medical device that received FDA 510(k) clearance on 2021-05-21. It is manufactured by Smtp Technology Co., Ltd.. The 510(k) number is K202299.

When was Ultrasonic Surgical Aspirator System approved by the FDA?

Ultrasonic Surgical Aspirator System received FDA 510(k) clearance on 2021-05-21, under approval number K202299.

What company makes Ultrasonic Surgical Aspirator System?

Ultrasonic Surgical Aspirator System is manufactured by Smtp Technology Co., Ltd..

What is the FDA product code for Ultrasonic Surgical Aspirator System?

The FDA product code for Ultrasonic Surgical Aspirator System is LFL.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Smtp Technology Co., Ltd.

K212750Ultrasonic Surgical Aspirator System, Model: XD880B K201274Ultrasonic Osteotomy Surgical System

Related Devices (Code: LFL)

K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, LLC K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC K151136HARMONIC HOOKEthicon Endo-Surgery, LLC K153299Tenex Health TX SystemTenex Health, Inc. K172691Ultrasonic GeneratorOlympus Medical Systems Corp.

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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