NEY
Solero Microwave Tissue Ablation (MTA) System and Accessories
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 68
Adverse events under product code NEY
product code NEY- Death
- 24
- Injury
- 388
- Malfunction
- 462
- Other
- 1
- Total
- 875
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NEY
- K252632 — Microwave Ablation Device
- K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
- K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS)
- K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A)
- K241825 — Microwave Ablation Antennas
- K240480 — IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
- K240784 — Temperature Sensor Probe (ABL-18TP20)
- K240518 — swiftPro System
- K233838 — Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B)
- K233140 — Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
- K231738 — NEUWAVE Microwave Ablation System and Accessories
- K232240 — Microwave Ablation System (BD-GT)
- K232241 — Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
- K223138 — AB1 Electrosurgical Instrument, Creo Electrosurgical System
- K222388 — swiftPro System
- K223581 — Solero Microwave Tissue Ablation (MTA) System and Accessories
- K221883 — Solero Microwave Tissue Ablation (MTA) System and Accessories
- K223272 — SurBlate Ablation System
- K221672 — Creo Electrosurgical System with NP1 Instrument
- K220472 — NEUWAVE Microwave Ablation System and Accessories
- K213067 — Solero Microwave Tissue Ablation (MTA) System and Accessories
- K201265 — Disposable Microwave Therapeutic Antennas
- K201262 — Microwave Therapeutic System
- K200298 — ABI Instrument, Creo Electrosurgical System
- K203303 — Emprint SX Ablation Platform with Thermosphere Technology
- K192406 — AveCure BT Microwave Ablation System
- K200081 — NEUWAVE Microwave Ablation System and Accessories
- K200003 — NP1 Instrument, Creo Electrosurgical System
- K200796 — Emprint Ablation System with Thermosphere Technology
- K200061 — HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
- K193232 — Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
- K183153 — Microwave Ablation System
- K182250 — Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
- K173756 — Certus 140 2.45GHz Ablation System
- K181941 — Swift System
- K180396 — miraDry System
- K171358 — Emprint SX Ablation Platform and Accessories
- K162449 — Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
- K163118 — FLEX Microwave Ablation System and Accessories
- K163105 — Emprint Ablation System
- K160141 — miraDry System
- K160936 — Certus 140 2.45GHz Ablation System
- K143203 — AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe
- K141785 — MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
- K133821 — EMPRINT ABLATION SYSTEM
- K130399 — CERTUS 140 CERTUSURGGT SURGICAL TOOL
- K122217 — CERTUS 140 2.45GHZ ABLATION SYSTEM
- K122762 — ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
- K113237 — CERTUS 140 2.45GHZ ABLATION SYSTEM
- K100744 — CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140
- K100786 — MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
- K094021 — ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I
- K083157 — HS AMICA
- K082819 — DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
- K082565 — MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
- K083537 — MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
- K072687 — VALLEYLAB MICROWAVE ABLATION GENERATOR
- K081042 — MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
- K072870 — MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
- K070356 — MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
- K070023 — MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
- K061865 — FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
- K053535 — VIVAWAVE MICROWAVE ABLATION SYSTEM
- K052919 — MICROSULIS TISSUE ABLATION SYSTEM
- K041340 — GUIDANT MICROWAVE ABLATION SYSTEM
- K011676 — VIVAWAVE MICROWAVE SYSTEM
- K013946 — FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
- K003978 — AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007
Data sourced from openFDA. This site is unofficial and independent of the FDA.