The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Solero Microwave Tissue Ablation (mta) System And Accessories.
| Device ID | K213067 |
| 510k Number | K213067 |
| Device Name: | Solero Microwave Tissue Ablation (MTA) System And Accessories |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Contact | Kasey E Newcomb |
| Correspondent | Kasey E Newcomb AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-23 |
| Decision Date | 2021-12-03 |