Home / 510(k) Clearances / K213067

510(k) K213067

Solero Microwave Tissue Ablation (MTA) System and Accessories by AngioDynamics, Inc. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2021
Date Received
September 23, 2021
Clearance Type
Special
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

Other clearances by AngioDynamics, Inc.

  • K252509 — AlphaVac Multipurpose Mechanical Aspiration System F1885 (November 24, 2025)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K242687 — NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Pro (December 6, 2024)
  • K240397 — AlphaVac MMA F1885 System (H787253020) (April 1, 2024)
  • K231945 — VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedu (July 20, 2023)
  • K223581 — Solero Microwave Tissue Ablation (MTA) System and Accessories (March 27, 2023)
  • K221883 — Solero Microwave Tissue Ablation (MTA) System and Accessories (March 7, 2023)
  • K213388 — AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (April 4, 2022)
  • K212386 — AngioVac F18 85 (September 30, 2021)
  • K211081 — AlphaVac Multipurpose Mechanical Aspiration (MMA) System (June 4, 2021)

Other clearances for product code NEY

  • K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II (March 2, 2026)
  • K252632 — Microwave Ablation Device (March 2, 2026)
  • K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS) (August 8, 2025)
  • K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A) (September 26, 2024)
  • K241825 — Microwave Ablation Antennas (September 20, 2024)
  • K240480 — IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave (July 19, 2024)
  • K240784 — Temperature Sensor Probe (ABL-18TP20) (May 29, 2024)
  • K240518 — swiftPro™ System (April 23, 2024)
  • K233838 — Emprint Ablation System with Thermosphere Technology (Overall System Name); Empr (March 28, 2024)
  • K233140 — Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact (January 31, 2024)