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 Stent, Ureteral
510(k) Number K212868
Device Name JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
Applicant
Rocamed SAM
9 Avenue Albert II
Monaco,  MC 98000
Applicant Contact Tahiana Rasolofoniaina
Correspondent
Rocamed SAM
9 Avenue Albert II
Monaco,  MC 98000
Correspondent Contact Tahiana Rasolofoniaina
Regulation Number876.4620
Classification Product Code
FAD  
Date Received09/09/2021
Decision Date 01/26/2022
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
-
-