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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 K090902
Device Name SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003
Applicant
Transenterix, Inc.
3908 Patriot Dr. Suite 170
Durham,  NC  27540
Applicant Contact TAMMY CARREA
Correspondent
Transenterix, Inc.
3908 Patriot Dr. Suite 170
Durham,  NC  27540
Correspondent Contact TAMMY CARREA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/01/2009
Decision Date 07/22/2009
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
Recalls CDRH Recalls
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