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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K102931
Device Name G-CINCH SUTURE GRASPER
Applicant
Usgi Medical
1140 Calle Cordillera
San Clemente,  CA  92673
Applicant Contact MARY LOU MOONEY
Correspondent
Usgi Medical
1140 Calle Cordillera
San Clemente,  CA  92673
Correspondent Contact MARY LOU MOONEY
Regulation Number876.1500
Classification Product Code
OCW  
Date Received10/04/2010
Decision Date 12/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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