FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
K Number: K040240
·
Decision Apr 1, 2004
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
11
Review Days
58
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Basic Information
- Device Name
- STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
- K Number
- K040240
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stellartech Research Corp.
- Date Received
- February 3, 2004
- Decision Date
- April 1, 2004
- 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 Stellartech Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K061544 | STELLARTECH 100 COAGULATION SYSTEM | Oct 13, 2006 | Substantially Equivalent |
| K050831 | STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A | Apr 12, 2005 | Substantially Equivalent |
| K042909 | STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A | Nov 12, 2004 | Substantially Equivalent |
| K041383 | STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 | Jun 14, 2004 | Substantially Equivalent |
| K032721 | MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | Oct 6, 2003 | Substantially Equivalent |
| K032452 | MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 | Aug 21, 2003 | Substantially Equivalent |
| K032062 | STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) | Jul 29, 2003 | Substantially Equivalent |
| K023765 | STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | Nov 29, 2002 | Substantially Equivalent |
| K013139 | STELLARTECH COAGULATION SYSTEM | Dec 18, 2001 | Substantially Equivalent |
| K994173 | STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230 | Jan 20, 2000 | Substantially Equivalent |