Mega Power Electrosurgical Generator
by Megadyne Medical Products, Inc.
510(k) K050579
Mega Power Electrosurgical Generator is a Class II device made by Megadyne Medical Products, Inc., cleared under FDA 510(k) K050579 on 24 Mar 2005, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050579 | Date24 Mar 2005 | StatusActive |
Official records
- FDA 510(k) database K050579
Recalls
-
- Terminated Z-2792-2018
If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
Timeline
- Cleared FDA 510(k) K050579
- Recall initiated FDA recalls Z-2792-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K050579
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Megadyne 1000 | 1000 / 1000 | 10614559103715 | On the market | |
| Megadyne 1300 | 1300 | 10614559101957 | No longer on the market | |
| Megadyne 1300-S | 1300-S | 10614559102879 | No longer on the market | |
| Megadyne 1300-U | 1300-U | 10614559102886 | No longer on the market | |
| Megadyne 1300SJ | 1300SJ / 1300SJ | 10614559105283 | On the market | |
| Megadyne 1300U | 1300U / 1300U | 10614559105290 | On the market | |
| Megadyne 1350 | 1350 | 10614559102893 | No longer on the market | |
| Megadyne 1400 | 1400 | 10614559101933 | No longer on the market | |
| Megadyne 1450 | 1450 | 10614559101940 | No longer on the market | |
| Megadyne 1450J | 1450J / 1450J | 10614559105276 | On the market | |
| MEGADYNE 1900 | 1900 | 10614559104682 | No longer on the market | |
| Megadyne 1910 | 1910 | 10614559103371 | No longer on the market | |
| Megadyne 1920 | 1920 | 10614559103937 | No longer on the market | |
| Megadyne 375003801 | 375003801 | 10614559105306 | No longer on the market | |
| Megadyne 375003802 | 375003802 | 10614559105313 | No longer on the market | |
| Megadyne 6020088-01 | 6020088-01 | 10614559103012 | No longer on the market | |
| Megadyne 6020088-02 | 6020088-02 | 10614559103975 | No longer on the market | |
| Megadyne 6020088-03 | 6020088-03 | 10614559104316 | No longer on the market | |
| Megadyne 6020088-R1 | 6020088-R1 | 10614559103968 | No longer on the market | |
| Megadyne 6020088-R2 | 6020088-R2 | 10614559104170 | No longer on the market | |
| Megadyne 6020088-R3 | 6020088-R3 | 10614559104507 | No longer on the market | |
| Megadyne 6020089-01 | 6020089-01 | 10614559103029 | No longer on the market | |
| Megadyne 6020090-01 | 6020090-01 | 10614559103036 | No longer on the market | |
| Megadyne 6020091-01 | 6020091-01 | 10614559103043 | No longer on the market | |
| Megadyne 6020092-01 | 6020092-01 | 10614559103050 | No longer on the market | |
| Megadyne 6020093-01 | 6020093-01 | 10614559103067 | No longer on the market | |
| Megadyne 6020094-01 | 6020094-01 | 10614559103074 | No longer on the market | |
| Megadyne 6020095-01 | 6020095-01 | 10614559103081 | No longer on the market | |
| Megadyne 6020096-02 | 6020096-02 | 10614559104309 | No longer on the market | |
| Megadyne 6020097-02 | 6020097-02 | 10614559104293 | No longer on the market | |
| Megadyne 6020098-01 | 6020098-01 | 10614559103111 | No longer on the market | |
| Megadyne 6020098-02 | 6020098-02 | 10614559103982 | No longer on the market | |
| Megadyne 6020099-01 | 6020099-01 | 10614559103128 | No longer on the market | |
| Megadyne 6020100-01 | 6020100-01 | 10614559103135 | No longer on the market | |
| Megadyne 6020162-01 | 6020162-01 | 10614559103340 | No longer on the market | |
| Megadyne 6020166-01 | 6020166-01 | 10614559103746 | No longer on the market | |
| Megadyne 6020167-01 | 6020167-01 | 10614559103753 | No longer on the market | |
| Megadyne 6020168-01 | 6020168-01 | 10614559103760 | No longer on the market | |
| Megadyne 6020169-01 | 6020169-01 | 10614559103777 | No longer on the market | |
| Megadyne 6020170-02 | 6020170-02 | 10614559104286 | No longer on the market | |
| Megadyne 6020171-02 | 6020171-02 | 10614559104279 | No longer on the market | |
| Megadyne 96007 | 96007 / 96007 | 10614559104415 | On the market |
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