FDA Product Code
FDA Product Code QNA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4690
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262200 | Stone Clear (BWSC-LP9-02) | Sonomotion, Inc. | 2026-07-29 | Special | PDF ↗ |
| DEN230082 | Stone Clear (SC-LP9-01) | Sonomotion, Inc. | 2024-10-30 | Direct | — |
Product code QNA · Class II · Gastroenterology, Urology. Data: openFDA.