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FDA 510(k)

Sonopet iQ Ultrasonic Aspirator System

K-Number: K190070 · 2019-04-11

ApplicantStryker Corporation
Decision Date2019-04-11
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Sonopet iQ Ultrasonic Aspirator System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2019-04-11 under 510(k) number K190070. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonopet iQ Ultrasonic Aspirator System?

Sonopet iQ Ultrasonic Aspirator System is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Stryker Corporation. The 510(k) number is K190070.

When did Sonopet iQ Ultrasonic Aspirator System receive FDA 510(k) clearance?

Sonopet iQ Ultrasonic Aspirator System received FDA 510(k) clearance on 2019-04-11, under 510(k) number K190070.

Who is the listed applicant for Sonopet iQ Ultrasonic Aspirator System?

The FDA 510(k) record lists Stryker Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonopet iQ Ultrasonic Aspirator System?

The FDA product code for Sonopet iQ Ultrasonic Aspirator System is LFL.

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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

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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