FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONMED HEATWAVE HAND-CONTROLLED ELETRODE
K Number: K021299
·
Decision Jun 26, 2002
Classifications
1
FEI Numbers
839
Registration Numbers
839
Same Product Code
2251
Applicant Total
90
Review Days
63
Basic Information
- Device Name
- CONMED HEATWAVE HAND-CONTROLLED ELETRODE
- K Number
- K021299
- 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
- CONMED CORP.
- Date Received
- April 24, 2002
- Decision Date
- June 26, 2002
- 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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|---|---|---|---|
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| K061021 | ENTAKE STANDARD AND SAFETY PEG SYSTEM | Apr 28, 2006 | Substantially Equivalent |
| K050992 | CONMED IRRIGATION NOZZLE | Jul 14, 2005 | Substantially Equivalent |
| K050777 | PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 | Apr 22, 2005 | Substantially Equivalent |
| K050304 | FX WIRE ADVANCED MEASUREMENT GUIDEWIRE | Mar 8, 2005 | Substantially Equivalent |
| K041953 | VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART | Aug 9, 2004 | Substantially Equivalent |
| K021079 | ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX | Jul 1, 2002 | Substantially Equivalent |
| K020135 | CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 | Apr 12, 2002 | Substantially Equivalent |
| K020186 | CONMED SYSTEM 5000 ESU | Apr 12, 2002 | Substantially Equivalent |
| K002002 | SUREFIT DISPERSIVE ELECTRODE | Aug 17, 2000 | Substantially Equivalent |