MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
FDA 510(k) clearance K080741 · decided 2008-12-16
Clearance details
- K-number
- K080741
- Device name
- MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
- Applicant
- Megadyne Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-17
- Decision date
- 2008-12-16
- Days to decision
- 274 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 |
|---|---|---|
| Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 200 recall (Z-2248-2024) | Megadyne Medical Products, Inc. | 2024-07-03 |
| MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode f recall (Z-1920-2024) | Megadyne Medical Products, Inc. | 2024-06-06 |
| MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery recall (Z-1997-2023) | Megadyne Medical Products, Inc. | 2023-06-30 |