CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR
FDA 510(k) clearance K052009 · decided 2005-09-28
Clearance details
- K-number
- K052009
- Device name
- CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR
- Applicant
- Conmed Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-07-25
- Decision date
- 2005-09-28
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Centennial, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurger recall (Z-1362-2011) | ConMed Electrosurgery | 2011-02-17 |
| ConMed System 2450 Electrosurgical Generator, REF 60-2450-120, 120 V, ConMed Electrosurger recall (Z-1363-2011) | ConMed Electrosurgery | 2011-02-17 |
| ConMed System 2450 Electrosurgical Generator, REF 60-2450-220, 220 V, ConMed Electrosurger recall (Z-1364-2011) | ConMed Electrosurgery | 2011-02-17 |
| ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed Electrosu recall (Z-1365-2011) | ConMed Electrosurgery | 2011-02-17 |
| ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished), Con recall (Z-1366-2011) | ConMed Electrosurgery | 2011-02-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ConMed PadPro Multifunction Electrodes (P200004/S001) | Conmed Corporation | 2022-06-16 |
| ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters (P200004) | Conmed Corporation | 2021-09-26 |