MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K080155
Device Name MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
Applicant
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale, 
CA 
94086 -5206

Applicant Contact michael h yramategui
Correspondent
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale, 
CA 
94086 -5206

Correspodent Contact michael h yramategui
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 01/23/2008
Decision Date 03/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No