The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Ethicon Megadyne Electrosurgical Generator.
| Device ID | K213696 |
| 510k Number | K213696 |
| Device Name: | ETHICON Megadyne Electrosurgical Generator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 |
| Contact | Sharon Sussex |
| Correspondent | Rubina Dosani Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati, OH 45242 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-23 |
| Decision Date | 2022-01-21 |