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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K221898
Device Name Gastrointestinal Boundary Identifier (GIBI HD)
Applicant
Reshape Lifesciences
1001 Calle Amanecer
San Clemente,  CA  92673
Applicant Contact Michelle Ravert
Correspondent
Reshape Lifesciences
1001 Calle Amanecer
San Clemente,  CA  92673
Correspondent Contact Michelle Ravert
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/30/2022
Decision Date 07/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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