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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K233020
Device Name TauTona Pneumoperitoneum Assist Device (TPAD)
Applicant
TauTona Group Research & Development, Co. LLC
604 Fifth Ave Suite D
Redwood City,  CA  94063
Applicant Contact Michael Blanchette
Correspondent
TauTona Group Research & Development, Co. LLC
604 Fifth Ave Suite D
Redwood City,  CA  94063
Correspondent Contact Michael Blanchette
Regulation Number884.1730
Classification Product Code
HIF  
Date Received09/22/2023
Decision Date 01/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT04392635
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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