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FDA 510(k)

Ultrasonic Surgical Aspirator System, Model: XD880B

K-Number: K212750 · 2021-09-27

ApplicantSmtp Technology Co., Ltd.
Decision Date2021-09-27
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Surgical Aspirator System, Model: XD880B is the device name listed in this FDA 510(k) record. The listed applicant is Smtp Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-27 under 510(k) number K212750. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasonic Surgical Aspirator System, Model: XD880B?

Ultrasonic Surgical Aspirator System, Model: XD880B is a medical device that received FDA 510(k) clearance on 2021-09-27. The listed applicant is Smtp Technology Co., Ltd.. The 510(k) number is K212750.

When did Ultrasonic Surgical Aspirator System, Model: XD880B receive FDA 510(k) clearance?

Ultrasonic Surgical Aspirator System, Model: XD880B received FDA 510(k) clearance on 2021-09-27, under 510(k) number K212750.

Who is the listed applicant for Ultrasonic Surgical Aspirator System, Model: XD880B?

The FDA 510(k) record lists Smtp Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasonic Surgical Aspirator System, Model: XD880B?

The FDA product code for Ultrasonic Surgical Aspirator System, Model: XD880B is LFL.

Other records listing Smtp Technology 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.

K202299Ultrasonic Surgical Aspirator SystemK201274Ultrasonic Osteotomy Surgical System

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.

K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLCK251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker InstrumentsK241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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