# 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 (

**Predicate Speed & CAPA Advisory Opportunity Score:** 36/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262244 |
| Device | 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 |
| Specialty / panel | Other |
| Product code | LFL |
| Device class | U |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-01 |
| Decision date | 2026-10-08 |
| Review time (days) | 99 |
| Third-party review | No |
| Applicant location | Portage, MI, US |

## Why this score
- Fast 99-day review: this device is a strong predicate for similar products.
- Posted 28 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262244). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
