Stone Clear (SC-LP9-01)
FDA 510(k) clearance DEN230082 · decided 2024-10-30
Clearance details
- K-number
- DEN230082
- Device name
- Stone Clear (SC-LP9-01)
- Applicant
- Sonomotion, Inc.
- Decision
- Unknown
- Date received
- 2023-12-07
- Decision date
- 2024-10-30
- Days to decision
- 328 days
- Clearance type
- Direct
- Product code
- QNA
- Device class
- 2
- Regulation number
- 876.4690
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Mateo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Stone Clear (BWSC-LP9-02) (K262200) | Sonomotion, Inc. | 2026-07-29 |
Recalls involving this device
No recalls on record reference this clearance.