SCOPEVALET DISPOSABLE BIOPSY VALVE


Device Classification Name

endoscopic irrigation/suction system

510(k) Number K122417
Device Name SCOPEVALET DISPOSABLE BIOPSY VALVE
Applicant
THE RUHOF CORP.
611 west 5th street
third floor
austin, 
TX 
78701

Applicant Contact kimberly mccoy
Correspondent
THE RUHOF CORP.
611 west 5th street
third floor
austin, 
TX 
78701

Correspodent Contact kimberly mccoy
Regulation Number 876.1500
Classification Product Code
OCX  
Date Received 08/08/2012
Decision Date 05/17/2013
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