The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Unify Multifunction Energy Platform, Cleanseal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless Footswitch, Unify Cart.
| Device ID | K213354 |
| 510k Number | K213354 |
| Device Name: | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
| Contact | Lisa Anderson |
| Correspondent | Lisa Anderson ConMed Corporation 525 French Road Utica, NY 13502 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-12 |
| Decision Date | 2022-03-11 |