QNAClass II
Ultrasonic Urinary Stone Propulsion Device
21 CFR 876.4690 / Gastroenterology, Urology
QNA is the FDA product code for Ultrasonic Urinary Stone Propulsion Device, a class II device type, regulated under 21 CFR 876.4690. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QNA
- Device name
- Ultrasonic Urinary Stone Propulsion Device
- FDA 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.
- Regulation
- 21 CFR 876.4690
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code QNA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code QNA| Applicant | Clearances |
|---|---|
| Sonomotion, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QNA.
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