Sonopet iQ Ultrasonic Aspirator System (K190070) - FDA 510(k) Clearance

K190070 is an FDA 510(k) clearance for the Sonopet iQ Ultrasonic Aspirator System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on April 11, 2019 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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