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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 K241039
Device Name ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
Applicant
Reshape Lifesciences
18 Technology Dr., Suite 110
Irvine,  CA  92618
Applicant Contact Eva Chang
Correspondent
Reshape Lifesciences
18 Technology Dr., Suite 110
Irvine,  CA  92618
Correspondent Contact Eva Chang
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/16/2024
Decision Date 05/16/2024
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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