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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 K091697
Device Name SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
Applicant
TRANSENTERIX, INC.
3908 PATRIOT DRIVE STE 170
DURHAM,  NC  27703
Applicant Contact TAMMY CARREA
Correspondent
TRANSENTERIX, INC.
3908 PATRIOT DRIVE STE 170
DURHAM,  NC  27703
Correspondent Contact TAMMY CARREA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/10/2009
Decision Date 09/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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