510(k) K223770

Sonopet 1Q 3 7cm 1Q Large by Stryker Corporation — Product Code LFL

K223770 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Sonopet 1Q 3 7cm 1Q Large". The FDA issued a decision of Substantially Equivalent on February 16, 2023. 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 16, 2023
Date Received
December 15, 2022
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