510(k) K262244
K262244 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the 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)". The FDA issued a decision of Substantially Equivalent on Oct 8, 2026. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Stryker Instruments has 76 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 8, 2026
- Date Received
- Jul 1, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)