FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOPCUT
K Number: K021525
·
Decision Jul 12, 2002
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
6
Review Days
63
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
- TOPCUT
- K Number
- K021525
- 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
- May 10, 2002
- Decision Date
- July 12, 2002
- 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
Other Clearances by H.S. Hospital Service S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K020987 | BMN I TYPE MARROW ASPIRATION NEEDLE | Jun 25, 2002 | Substantially Equivalent |
| K013692 | TRAPSYSTEM SET | Feb 5, 2002 | Substantially Equivalent |
| K002947 | BIOMOL ASPIRATION BIOPSY NEEDLE | Dec 19, 2000 | Substantially Equivalent |
| K002944 | PRECISA BIOPSY NEEDLE | Dec 19, 2000 | Substantially Equivalent |
| K002946 | SILENT BIOPSY NEEDLE | Dec 19, 2000 | Substantially Equivalent |