FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15
K Number: K981416
·
Decision Jun 24, 1998
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
7
Review Days
65
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Basic Information
- Device Name
- MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15
- K Number
- K981416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Magna Advanced Technologies, Inc.
- Date Received
- April 20, 1998
- Decision Date
- June 24, 1998
- 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 Magna Advanced Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991819 | MAGNATEK 30 | Aug 19, 1999 | Substantially Equivalent |
| K982907 | MAGNATEK 40 | Oct 2, 1998 | Substantially Equivalent |
| K983114 | MAGNATEK80 | Sep 22, 1998 | Substantially Equivalent |
| K982846 | MTEK-1400 | Sep 18, 1998 | Substantially Equivalent |
| K982405 | MTEK-1000 | Sep 17, 1998 | Substantially Equivalent |
| K981310 | MAGNATEK C-300 | Jul 9, 1998 | Substantially Equivalent |