Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K122417
Device Name SCOPEVALET DISPOSABLE BIOPSY VALVE
Applicant
The Ruhof Corp.
611 W. 5th St. Third Floor
Austin,  TX  78701
Applicant Contact KIMBERLY MCCOY
Correspondent
The Ruhof Corp.
611 W. 5th St. Third Floor
Austin,  TX  78701
Correspondent Contact KIMBERLY MCCOY
Regulation Number876.1500
Classification Product Code
OCX  
Date Received08/08/2012
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
Predetermined Change
Control Plan Authorized		 No
-
-