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FDA 510(k)

Sonopet iQ Ultrasonic Aspirator System (5500-050-000)

K-Number: K243930 · 2025-03-24

ApplicantStryker Instruments
Decision Date2025-03-24
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Sonopet iQ Ultrasonic Aspirator System (5500-050-000) is a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2025-03-24 under approval number K243930. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonopet iQ Ultrasonic Aspirator System (5500-050-000)?

Sonopet iQ Ultrasonic Aspirator System (5500-050-000) is a medical device that received FDA 510(k) clearance on 2025-03-24. It is manufactured by Stryker Instruments. The 510(k) number is K243930.

When was Sonopet iQ Ultrasonic Aspirator System (5500-050-000) approved by the FDA?

Sonopet iQ Ultrasonic Aspirator System (5500-050-000) received FDA 510(k) clearance on 2025-03-24, under approval number K243930.

What company makes Sonopet iQ Ultrasonic Aspirator System (5500-050-000)?

Sonopet iQ Ultrasonic Aspirator System (5500-050-000) is manufactured by Stryker Instruments.

What is the FDA product code for Sonopet iQ Ultrasonic Aspirator System (5500-050-000)?

The FDA product code for Sonopet iQ Ultrasonic Aspirator System (5500-050-000) is LFL.

Related Clinical Trials

NCT05372679 REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study / ACTIVE_NOT_RECRUITING NCT07508722 Transcranial Ultrasonic Neuromodulation of Primary Visual Cortex and Primary Auditory Cortex in Humans NOT_YET_RECRUITING

Related PubMed Literature

PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020)

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Related Devices (Code: LFL)

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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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