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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
510(k) Number K151001
Device Name MUSE System
Applicant
Medigus , Ltd.
Bldg. 7a, Omer Imdustrial Park
Omer,  IL 84965
Applicant Contact YANIV SAGIE
Correspondent
Sheila S. Stevens
2121 N.California Blvd.
Suite #290
Walnut Creek,  CA  94596
Correspondent Contact SHEILA S. STEVENS
Regulation Number876.1500
Classification Product Code
ODE  
Date Received04/15/2015
Decision Date 06/05/2015
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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