The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch.
| Device ID | K193145 |
| 510k Number | K193145 |
| Device Name: | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 |
| Contact | Sharon Sussex |
| Correspondent | Kweku Biney Ethicon Endo-Surgery LLC 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 | 2019-11-13 |
| Decision Date | 2020-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10614559105597 | K193145 | 000 |
| 10614559105634 | K193145 | 000 |