510(k) K162449
K162449 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)". The FDA issued a decision of Substantially Equivalent on May 5, 2017. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. AngioDynamics, Inc. has 89 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2017
- Date Received
- Sep 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
- 510(k)