FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Stone Clear (SC-LP9-01)
K Number: DEN230082
·
Decision Oct 30, 2024
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
3
Review Days
328
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Basic Information
- Device Name
- Stone Clear (SC-LP9-01)
- K Number
- DEN230082
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.4690
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Sonomotion, Inc.
- Date Received
- December 7, 2023
- Decision Date
- October 30, 2024
- Product Code
- QNA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QNA | Ultrasonic Urinary Stone Propulsion Device | FDA class 2 | Gastroenterology, Urology |