K223770 - Sonopet 1Q 3 7cm 1Q Large

K223770 is an FDA 510(k) clearance for the Sonopet 1Q 3 7cm 1Q Large. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on February 16, 2023 after a review of 63 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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