FDA product code NQU: Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
NQU is the FDA product code for dislodger, stone, basket, ureteral, metal, reprocessed. It is a Class II device, regulated under 21 CFR 876.4680 and reviewed by the Gastroenterology and Urology panel. Devices under NQU reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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).
Classification
| Field | Value |
|---|---|
| Device name | Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.4680 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NQU devices
openFDA lists no recalls for product code NQU.
Frequently asked questions
What is FDA product code NQU?
NQU is the FDA product code for dislodger, stone, basket, ureteral, metal, reprocessed. It is a Class II device, regulated under 21 CFR 876.4680 and reviewed by the Gastroenterology and Urology panel.
What device class is NQU?
Class II, regulation 21 CFR 876.4680. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NQU
- Run a recall and safety report across every NQU manufacturer
- Watch product code NQU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times