FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARBODISSECTING ENDOSCOPE
K Number: K020925
·
Decision Apr 29, 2003
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
13
Applicant Total
2
Review Days
404
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Basic Information
- Device Name
- CARBODISSECTING ENDOSCOPE
- K Number
- K020925
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endo Surgical Devices, Inc.
- Date Received
- March 21, 2002
- Decision Date
- April 29, 2003
- Product Code
- DWX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWX | Stripper, Artery, Intraluminal | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWX), ordered by most recent decision date.
MOLLRING MULTITASC
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ENDOHELIX ENDARTERECTOMY DEVICE
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VASCULAR ARCHITECTS PERISCOPE DEVICE
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FDA Class 2
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MOLLRING CUTTER
FDA 510(k)
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EXTERNAL VEIN STRIPPER
FDA 510(k)
FDA Class 2
·Cardiovascular
INTRALUMINAL ARTERY STRIPPER
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Endo Surgical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013680 | CARBODISSECTING ENDOSCOPE | Mar 4, 2002 | Substantially Equivalent |