Product code NQU

Device name

Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.4680

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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).

Source

FDA openFDA device classification dataset