Device |
dislodger, stone, basket, ureteral, metal, reprocessed |
Regulation Description |
Ureteral stone dislodger. |
Definition |
A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | NQU |
Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
876.4680
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|
|
|