DeviceClearance

Product code QNA— Gastroenterology, Urology

Stone Clear (BWSC-LP9-02)

Classification name
Ultrasonic Urinary Stone Propulsion Device
Device class
Class 2
Regulation
21 CFR 876.4690
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QNA under 21 CFR 876.4690, via openFDA

Market context for product code QNA

FDA has cleared 2 devices under product code QNA between 2024 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNA

Recent clearances under product code QNA

Data sourced from openFDA. This site is unofficial and independent of the FDA.