510(k) K243930
K243930 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "Sonopet iQ Ultrasonic Aspirator System (5500-050-000)". The FDA issued a decision of Substantially Equivalent on March 24, 2025. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Stryker Instruments has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2025
- Date Received
- December 20, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type