HYFRECATOR, #733
FDA 510(k) clearance K800617 · decided 1980-05-02
Clearance details
- K-number
- K800617
- Device name
- HYFRECATOR, #733
- Applicant
- Birtcher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-03-18
- Decision date
- 1980-05-02
- Days to decision
- 45 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyf recall (Z-0826-2013) | ConMed Corporation | 2013-02-15 |
| ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable recall (Z-0827-2013) | ConMed Corporation | 2013-02-15 |
| ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalo recall (Z-0718-2013) | ConMed Corporation | 2013-01-24 |
| ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalo recall (Z-0719-2013) | ConMed Corporation | 2013-01-24 |