FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE USE BLADE ELECTRODE
K Number: K780977
·
Decision Jun 22, 1978
Classifications
1
FEI Numbers
839
Registration Numbers
839
Same Product Code
2251
Applicant Total
55
Review Days
13
Basic Information
- Device Name
- SINGLE USE BLADE ELECTRODE
- K Number
- K780977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- ASPEN LABORATORIES, INC.
- Date Received
- June 9, 1978
- Decision Date
- June 22, 1978
- 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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| K953081 | BEAMER PLUS | Oct 30, 1995 | Substantially Equivalent |
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| K946104 | SMOKIEVAC ELECTROSURGICAL PENCIL | Apr 3, 1995 | Substantially Equivalent |
| K944012 | ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR | Dec 21, 1994 | Substantially Equivalent |
| K924960 | EXCALIBUR ELECTROSURGICAL UNIT | Apr 16, 1993 | Substantially Equivalent |
| K913213 | SINGLE USE LEE ELECTRODE | Feb 13, 1992 | Substantially Equivalent |