BIOPSY VALVE


Device Classification Name

endoscopic irrigation/suction system

510(k) Number K111821
Device Name BIOPSY VALVE
Applicant
ENDOCHOICE, INC.
11810 wills road
suite 100
alpharetta, 
GA 
30009

Applicant Contact theron gober
Correspondent
ENDOCHOICE, INC.
11810 wills road
suite 100
alpharetta, 
GA 
30009

Correspodent Contact theron gober
Regulation Number 876.1500
Classification Product Code
OCX  
Date Received 06/28/2011
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No