Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2025-03-24 under 510(k) 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. The listed applicant is Stryker Instruments. The 510(k) number is K243930.

When did Sonopet iQ Ultrasonic Aspirator System (5500-050-000) receive FDA 510(k) clearance?

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

Who is the listed applicant for Sonopet iQ Ultrasonic Aspirator System (5500-050-000)?

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

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

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.

NCT03072927MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims StudyRECRUITINGNCT07392333A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back PainRECRUITING

Other records listing Stryker Instruments 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.

K261544Hydro Irrigation SystemK253679Hydro Irrigation SystemK252282SurgiCount+ SystemK251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip PointerK250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)

View all 20 devices →

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.K241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.

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.

↑