• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • 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 dissolvable gel for preventing ureteral stone migration
Regulation Description Ureteral stone dislodger.
Definition For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
Product CodeONJ
Regulation Number 876.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
PLUROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-