The following data is part of a premarket notification filed by Dornier Medtech America Inc. with the FDA for Electrosurgical Accessory.
| Device ID | K210394 |
| 510k Number | K210394 |
| Device Name: | Electrosurgical Accessory |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | Dornier MedTech America Inc. 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer Dornier MedTech America Inc. 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-10 |
| Decision Date | 2021-05-19 |