K262244 - Sonopet iQ Series III Console (5700-050-000)

K262244 is an FDA 510(k) clearance for the Sonopet iQ Series III Console (5700-050-000). Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on October 8, 2026 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.