FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGITRON
K Number: K990146
·
Decision Mar 17, 1999
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
15
Review Days
57
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Basic Information
- Device Name
- SURGITRON
- K Number
- K990146
- 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
- Ellman Intl., Inc.
- Date Received
- January 19, 1999
- Decision Date
- March 17, 1999
- 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 Ellman Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013255 | SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF | Nov 7, 2001 | Substantially Equivalent |
| K003126 | BIPOLAR TRIGGER-FLEX PROBE | Apr 11, 2001 | Substantially Equivalent |
| K001986 | SURGITRON IEC II | Sep 27, 2000 | Substantially Equivalent |
| K001407 | SURGITRON IEC II | Jul 24, 2000 | Substantially Equivalent |
| K001253 | SURGITRON IEC II | May 26, 2000 | Substantially Equivalent |
| K992382 | SURGITRON RADIOLASE | Oct 14, 1999 | Substantially Equivalent |
| K980177 | SUGITRON MODEL: IEC | Jul 7, 1998 | Substantially Equivalent |
| K980170 | SURGITRON | Jun 29, 1998 | Substantially Equivalent |
| K972072 | SURGITRON MODEL FFPF-EMC | Jun 19, 1997 | Substantially Equivalent |
| K955176 | DENTO-SURGE | Apr 15, 1996 | Substantially Equivalent |