Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade
Summary
Stryker Instruments received 510(k) clearance for 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), a LFL device. Cleared on 2026-10-08.
Details
Source
510(k) Clearance
External ID
K262244
Action Date
2026-10-08
Status
Traditional
Category
device
Product Code
LFL
Product Description
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). Product code: LFL.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 502 device clearances issued this month. Stryker Instruments has received 19 total clearances in our database.
Stryker Instruments has 20 FDA actions in our database, including 1 recall and 19 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Stryker Instruments have FDA actions?
Stryker Instruments has 20 FDA actions in our database, including 1 recall and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K262244" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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