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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K122299
Device Name SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR
Applicant
Transenterix, Inc.
635 Davis Dr., Suite 300
Durham,  NC  27713
Applicant Contact TAMMY B CARREA
Correspondent
Transenterix, Inc.
635 Davis Dr., Suite 300
Durham,  NC  27713
Correspondent Contact TAMMY B CARREA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/31/2012
Decision Date 10/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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