FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Sonablate 450
K Number: DEN150011
·
Decision Oct 9, 2015
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
12
Applicant Total
2
Review Days
200
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Basic Information
- Device Name
- Sonablate 450
- K Number
- DEN150011
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.4340
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Sonacare Medical, LLC
- Date Received
- March 23, 2015
- Decision Date
- October 9, 2015
- Product Code
- PLP
- 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 |
|---|---|---|---|
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Sonacare Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K160942 | Sonablate | Dec 21, 2016 | Substantially Equivalent |