ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES
FDA 510(k) clearance K943055 · decided 1994-12-21
Clearance details
- K-number
- K943055
- Device name
- ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES
- Applicant
- Megadyne Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-27
- Decision date
- 1994-12-21
- Days to decision
- 177 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
- Draper, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE recall (Z-0468-03) | Megadyne Medical Products, Inc | 2003-01-30 |
| Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only recall (Z-0469-03) | Megadyne Medical Products, Inc | 2003-01-30 |