DeviceClearance

Sonopet iQ Series III Console (5700-050-000) +6 more— 510(k) K262244

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K262244 for Sonopet iQ Series III Console (5700-050-000) +6 more, Substantially Equivalent on 2026-10-08. Applicant: Stryker Instruments. Device class: Unclassified.

Summary

This Stryker Instruments clearance covers the Sonopet iQ Series III Console plus Sonopet iQ+ accessories: a straight handpiece, 10 mm and 20 mm blades, an 11 cm Apex Knife, a 12 cm Apex 360, and a 12 cm Claw. Product code LFL is ultrasonic surgical instruments.

The record lists the device class as U (unclassified), gives no regulation number, and shows the advisory panel as Unknown. It went through as a Traditional 510(k).

Stryker Instruments filed from Portage, Michigan. Review took 99 days (July 1 to October 8, 2026).

Clearance details

Device name as filed
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)
Applicant
Stryker Instruments
Product code
Product code LFL
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Portage, MI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LFL

view all

More clearances from Stryker Instruments

view all

Adverse events under product code LFL

product code LFL
Death
29
Injury
1,046
Malfunction
21,642
Total
22,717

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.