FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOMOL ASPIRATION BIOPSY NEEDLE
K Number: K002947
·
Decision Dec 19, 2000
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- BIOMOL ASPIRATION BIOPSY NEEDLE
- K Number
- K002947
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- H.S. Hospital Service S.R.L.
- Date Received
- September 21, 2000
- Decision Date
- December 19, 2000
- 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
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Other Clearances by H.S. Hospital Service S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K021525 | TOPCUT | Jul 12, 2002 | Substantially Equivalent |
| K020987 | BMN I TYPE MARROW ASPIRATION NEEDLE | Jun 25, 2002 | Substantially Equivalent |
| K013692 | TRAPSYSTEM SET | Feb 5, 2002 | Substantially Equivalent |
| K002944 | PRECISA BIOPSY NEEDLE | Dec 19, 2000 | Substantially Equivalent |
| K002946 | SILENT BIOPSY NEEDLE | Dec 19, 2000 | Substantially Equivalent |