FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UreTron MultiProbe Lithotripter System
K Number: K160198
·
Decision Feb 23, 2016
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
3
Review Days
26
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Basic Information
- Device Name
- UreTron MultiProbe Lithotripter System
- K Number
- K160198
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Med-Sonics Corp.
- Date Received
- January 28, 2016
- Decision Date
- February 23, 2016
- Product Code
- FFK
- 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 |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | FDA class 2 | Gastroenterology, Urology |
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