FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
K Number: K073399
·
Decision Dec 21, 2007
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
4
Review Days
17
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Basic Information
- Device Name
- TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
- K Number
- K073399
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Envisioneering, LLC
- Date Received
- December 4, 2007
- Decision Date
- December 21, 2007
- Product Code
- FCG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
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