FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROCAUTERY PROBE
K Number: K910334
·
Decision Feb 21, 1991
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
21
Review Days
27
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Basic Information
- Device Name
- ELECTROCAUTERY PROBE
- K Number
- K910334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Wiltek Medical, Inc.
- Date Received
- January 25, 1991
- Decision Date
- February 21, 1991
- 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 Wiltek Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990231 | WILTEK HOT BIOPSY FORCEPS | Apr 13, 1999 | Substantially Equivalent |
| K922989 | WILTEK IRRIGAITON/ASPIRATION TUBE SET | Feb 15, 1994 | Substantially Equivalent |
| K930419 | WILTEK BIOPSY FORCEPS | Jun 1, 1993 | Substantially Equivalent |
| K914882 | WILTEK BALLOON CHOLANGIOGRAPHY CATHETER | Jan 7, 1992 | Substantially Equivalent |
| K914881 | WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Jan 7, 1992 | Substantially Equivalent |
| K914132 | WILTEK ELECTROCAUTERY ACTIVE CORD | Sep 25, 1991 | Substantially Equivalent |
| K914131 | WILTEK ELECTROCAUTERY ADAPTOR | Sep 25, 1991 | Substantially Equivalent |
| K912122 | CHOLANGIOGRAPHY CATHETER | Sep 23, 1991 | Substantially Equivalent |
| K912288 | WILTEK STANDARD CHOLANGIOGRAPHY CATHETER | Sep 23, 1991 | Substantially Equivalent |
| K894866 | WILTEK STONE EXTRACTOR | Dec 21, 1989 | Substantially Equivalent |