INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER


Device Classification Name

system,surgical,computer controlled instrument

510(k) Number K080291
Device Name INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
Applicant
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale, 
CA 
94086 -5206

Applicant Contact karen uyesugi
Correspondent
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale, 
CA 
94086 -5206

Correspodent Contact karen uyesugi
Regulation Number 876.1500
Classification Product Code
NAY  
Date Received 02/04/2008
Decision Date 03/19/2008
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

Recalls CDRH Recalls