• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K122505
Device Name SINGLE USE PRELOADED SPHINCTEROTOME V
Original Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
regulatory affairs & quality assurance
3500 corporate parkway
center valley,  PA  18034 -0610
Original Contact sheri musgnung
Regulation Number876.4300
Classification Product Code
KNS  
Date Received08/16/2012
Decision Date 04/11/2013
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
-
-