ENDOWRIST ONE SUCTION/IRRIGATOR


Device Classification Name

system,surgical,computer controlled instrument

510(k) Number K110451
Device Name ENDOWRIST ONE SUCTION/IRRIGATOR
Applicant
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale, 
CA 
94086

Applicant Contact brandon hansen
Correspondent
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale, 
CA 
94086

Correspodent Contact brandon hansen
Regulation Number 876.1500
Classification Product Code
NAY  
Date Received 02/16/2011
Decision Date 08/26/2011
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