MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
FDA 510(k) clearance K021077 · decided 2002-04-17
Clearance details
- K-number
- K021077
- Device name
- MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
- Applicant
- Megadyne Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-03
- Decision date
- 2002-04-17
- Days to decision
- 14 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
- Cincinnati, OH, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" recall (Z-2249-2024) | Megadyne Medical Products, Inc. | 2024-07-03 |
| MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery recall (Z-1995-2023) | Megadyne Medical Products, Inc. | 2023-06-30 |