The following data is part of a premarket notification filed by Angiodynamics, Inc with the FDA for Solero Mta System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),solero Microwave Tissue Ablation Applicator (29cm).
| Device ID | K162449 |
| 510k Number | K162449 |
| Device Name: | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-01 |
| Decision Date | 2017-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787700106003US0 | K162449 | 000 |
| H787700106002US0 | K162449 | 000 |
| H787700106001US0 | K162449 | 000 |
| H78712740000US0 | K162449 | 000 |