NQU

Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

Product code

NQU

Device name

Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

Device class

Class 2

21 CFR

21 CFR 876.4680

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).