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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K223770
Device Name Sonopet 1Q 3 7cm 1Q Large
Applicant
Stryker Corporation
1941 Stryker Way
Portage,  MI  49002
Applicant Contact Thomas Flannelly
Correspondent
Stryker Corporation
1941 Stryker Way
Portage,  MI  49002
Correspondent Contact Thomas Flannelly
Classification Product Code
LFL  
Date Received12/15/2022
Decision Date 02/16/2023
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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