510(k) clearance

Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)

FDA 510(k) source

510(k) number

K262244

Applicant

Stryker Instruments

Decision date

Oct 8, 2026

Date received

Jul 1, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LFL

Device type

Instrument, Ultrasonic Surgical

Device class

Unclassified

Advisory committee

Unknown

Statement or summary

Summary

Third party

N

Location

Portage, MI, US