FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
K Number: K973554
·
Decision Dec 19, 1997
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
27
Review Days
91
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Basic Information
- Device Name
- VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
- K Number
- K973554
- 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
- September 19, 1997
- Decision Date
- December 19, 1997
- Product Code
- JOS
- 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 |
|---|---|---|---|
| JOS | Electrode, Electrosurgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Valley Forge Scientific Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K050364 | MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM | Mar 9, 2005 | Substantially Equivalent |
| K042604 | VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS | Oct 22, 2004 | Substantially Equivalent |
| K032601 | STRYKER INTERVENTIONAL PAIN RF GENERATOR | Apr 1, 2004 | Substantially Equivalent |
| K033499 | MALIS IRRIGATION MODULE 1000 | Nov 28, 2003 | Substantially Equivalent |
| K982229 | BI-DENT | Aug 13, 1998 | 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 |
| K955346 | VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM | Dec 8, 1995 | Substantially Equivalent |
| K951985 | PRECISION BIPOLAR COAGULATOR | May 23, 1995 | Substantially Equivalent |