Product code
QMK: Extracorporeal acoustic wave generating accessory to urological indwelling catheter for use during public health emergen
FDA product code · Not Classified · Gastroenterology/Urology
Key facts
| Product code | QMK |
|---|---|
| Device | Extracorporeal acoustic wave generating accessory to urological indwelling catheter for use during public health emergen |
| Device class | Not Classified |
| Review panel | Gastroenterology/Urology |
| Submission type | Enforcement Discretion |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device is an acoustic wave generating extracorporeal accessory to indwelling urinary catheters intended to aid in the reduction of catheter-associated urinary tract infection (CAUTI) incidence in patients requiring long-term (= 14 days) indwelling catheterization. Intended for use during declared public health emergency. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database