510(k) K213824

Sonopet iQ Ultrasonic Aspirator System by Stryker Corporation — Product Code LFL

K213824 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Sonopet iQ Ultrasonic Aspirator System". The FDA issued a decision of Substantially Equivalent on February 3, 2022. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Stryker Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2022
Date Received
December 8, 2021
Clearance Type
Special
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