||dissolvable gel for preventing ureteral stone migration|
||Ureteral stone dislodger.|
||For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
||The device is an injectable gel that is capable of being dissolved using endoscopic irrigation.
||The gel temporarily obstructs the ureter to limit the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures. After the lithotripsy procedure, the gel is dissolved using irrigation.
||The target area is the ureter.
|Regulation Medical Specialty
Office of Device Evaluation
Division of Reproductive, Gastro-Renal, and Urological Devices
Urology and Lithotripsy Devices Branch (ULDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
| Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.|
|Third Party Review
||Not Third Party Eligible