INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000


Device Classification Name

system,surgical,computer controlled instrument

510(k) Number K081137
Device Name INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
Applicant
INTUITIVE SURGICAL, INC.
1266 kifer road
building 101
sunnyvale, 
CA 
94086 -5206

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

Correspodent Contact karen uyesugi
Regulation Number 876.1500
Classification Product Code
NAY  
Date Received 04/21/2008
Decision Date 02/18/2009
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

Recalls CDRH Recalls