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. |
Physical State |
The device is an injectable gel that is capable of being dissolved using endoscopic irrigation. |
Technical Method |
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. |
Target Area |
The target area is the ureter. |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | ONJ |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(K) Exempt
|
Regulation Number |
876.4680
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
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 exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures 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 requirements of FDAMA and the Cures Act. |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |