QNA — Ultrasonic Urinary Stone Propulsion Device Class II
FDA product code QNA covers "Ultrasonic Urinary Stone Propulsion Device", a Class II medical device regulated under 21 CFR 876.4690. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QNA
- Device Class
- Class II
- Regulation Number
- 876.4690
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
An ultrasonic urinary stone propulsion device visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones to facilitate their passage.