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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Insulin
510(k) Number K223372
Device Name Omnipod GO Insulin Delivery Device
Applicant
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Lauren Davis
Correspondent
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Danna Zylka
Regulation Number880.5725
Classification Product Code
LZG  
Date Received11/04/2022
Decision Date 04/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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