510(k) K243930

Sonopet iQ Ultrasonic Aspirator System (5500-050-000) by Stryker Instruments — Product Code LFL

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