The following data is part of a premarket notification filed by Ellusa, Llc with the FDA for Ellusa Reusable Bipolar Cable.
| Device ID | K222429 |
| 510k Number | K222429 |
| Device Name: | Ellusa Reusable Bipolar Cable |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510 |
| Contact | Suzanne Lucas |
| Correspondent | Suzanne Lucas Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-11 |
| Decision Date | 2022-09-09 |