HYFRECATOR 2000
FDA 510(k) clearance K970493 · decided 1997-04-30
Clearance details
- K-number
- K970493
- Device name
- HYFRECATOR 2000
- Applicant
- Aspen Labs
- Decision
- Substantially Equivalent
- Date received
- 1997-02-10
- Decision date
- 1997-04-30
- Days to decision
- 79 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 |
|---|---|---|
| Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal recall (Z-0144-04) | ConMed Electrosurgery | 2003-11-19 |