FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESTO BREAST BIOPSY DEVICE
K Number: K133702
·
Decision Feb 28, 2014
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
353
Applicant Total
2
Review Days
87
Basic Information
- Device Name
- PRESTO BREAST BIOPSY DEVICE
- K Number
- K133702
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SONTINA MEDICAL, LLC
- Date Received
- December 3, 2013
- Decision Date
- February 28, 2014
- Product Code
- KNW
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by SONTINA MEDICAL, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K120440 | PRESTO BREAST BIOPSY DEVICE | May 17, 2012 | Substantially Equivalent |