FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO VNUS CLOSURE SYSTEM
K Number: K030557
·
Decision Mar 11, 2003
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
9
Review Days
18
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Basic Information
- Device Name
- MODIFICATION TO VNUS CLOSURE SYSTEM
- K Number
- K030557
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vnus Medical Technologies, Inc.
- Date Received
- February 21, 2003
- Decision Date
- March 11, 2003
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Vnus Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082890 | VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 | Oct 15, 2008 | Substantially Equivalent |
| K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 | Aug 1, 2006 | Substantially Equivalent |
| K052003 | VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) | Oct 11, 2005 | Substantially Equivalent |
| K040638 | VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 | Jun 7, 2004 | Substantially Equivalent |
| K033547 | VNUS VESSEL AND TISSUE COAGULATION SYSTEM | Jan 7, 2004 | Substantially Equivalent |
| K003092 | MODIFICATION TO VNUS CLOSURE SYSTEM | Dec 18, 2000 | Substantially Equivalent |
| K982816 | VNUS CLOSURE SYSTEM | Mar 17, 1999 | Substantially Equivalent |
| K974521 | VNUS CLOSURE SYSTEM | Feb 20, 1998 | Substantially Equivalent |