MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
FDA 510(k) clearance K133726 · decided 2014-01-24
Clearance details
- K-number
- K133726
- Device name
- MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
- Applicant
- Megadyne Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-06
- Decision date
- 2014-01-24
- Days to decision
- 49 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient recall (Z-0597-2024) | Megadyne Medical Products, Inc. | 2023-12-26 |
| MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery recall (Z-1998-2023) | Megadyne Medical Products, Inc. | 2023-06-30 |
| MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery recall (Z-1999-2023) | Megadyne Medical Products, Inc. | 2023-06-30 |
| MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurger recall (Z-2000-2023) | Megadyne Medical Products, Inc. | 2023-06-30 |
| MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery recall (Z-2001-2023) | Megadyne Medical Products, Inc. | 2023-06-30 |