FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM
K Number: K955346
·
Decision Dec 8, 1995
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
27
Review Days
17
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Basic Information
- Device Name
- VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM
- K Number
- K955346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Valley Forge Scientific Corp.
- Date Received
- November 21, 1995
- Decision Date
- December 8, 1995
- 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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| K033499 | MALIS IRRIGATION MODULE 1000 | Nov 28, 2003 | Substantially Equivalent |
| K982229 | BI-DENT | Aug 13, 1998 | Substantially Equivalent |
| K973554 | VALLEY FORGE BIPOLAR BALL TIP ELECTRODE | Dec 19, 1997 | Substantially Equivalent |
| K971986 | VALLEY FORGE BIPOLAR LOOP | Aug 26, 1997 | Substantially Equivalent |
| K964143 | MINI-SYMM BIPOLAR COAGULATOR | Jan 9, 1997 | Substantially Equivalent |
| K955764 | VALLEY FORGE BIPLOAR LOOP | Mar 1, 1996 | Substantially Equivalent |
| K951985 | PRECISION BIPOLAR COAGULATOR | May 23, 1995 | Substantially Equivalent |