INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE


Device Classification Name

system,surgical,computer controlled instrument

510(k) Number K081207
Device Name INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
Applicant
INTUITIVE SURGICAL, INC.
1266 kifer road
building 101
sunnyvale, 
CA 
94086 -5206

Applicant Contact jerry tsutsumi
Correspondent
INTUITIVE SURGICAL, INC.
1266 kifer road
building 101
sunnyvale, 
CA 
94086 -5206

Correspodent Contact jerry tsutsumi
Regulation Number 876.1500
Classification Product Code
NAY  
Date Received 04/29/2008
Decision Date 12/19/2008
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