NQU — Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed Class II
FDA product code NQU covers "Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed", a Class II medical device regulated under 21 CFR 876.4680. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- NQU
- Device Class
- Class II
- Regulation Number
- 876.4680
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).