FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAURUS NEEDLE CORE BIOPSY SYSTEM
K Number: K960317
·
Decision Mar 15, 1996
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
4
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LAURUS NEEDLE CORE BIOPSY SYSTEM
- K Number
- K960317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laurus Medical Corp.
- Date Received
- January 23, 1996
- Decision Date
- March 15, 1996
- Product Code
- FCG
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCG), ordered by most recent decision date.
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ClearTip FNA and FNB Types
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Precision GI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ClearTip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology