Cleared Traditional

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

K243930 · Stryker Instruments · General & Plastic Surgery
Mar 2025
Decision
94d
Days
Risk

About This 510(k) Submission

K243930 is an FDA 510(k) clearance for the Sonopet iQ Ultrasonic Aspirator System (5500-050-000), a Instrument, Ultrasonic Surgical, submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on March 24, 2025, 94 days after receiving the submission on December 20, 2024. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K243930 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2024
Decision Date March 24, 2025
Days to Decision 94 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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