FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K003978 |
AFX, INC. |
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 |
05/22/2001 |
K013946 |
AFX, INC. |
FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM |
02/27/2002 |
K162449 |
ANGIODYNAMICS, INC |
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) |
05/05/2017 |
K213067 |
AngioDynamics, Inc. |
Solero Microwave Tissue Ablation (MTA) System and Accessories |
12/03/2021 |
K221883 |
AngioDynamics, Inc. |
Solero Microwave Tissue Ablation (MTA) System and Accessories |
03/07/2023 |
K223581 |
AngioDynamics, Inc. |
Solero Microwave Tissue Ablation (MTA) System and Accessories |
03/27/2023 |
K182250 |
AngioDynamics, Inc. |
Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) |
02/28/2019 |
K141785 |
BSD MEDICAL CORP. |
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES |
03/31/2015 |
K100786 |
BSD MEDICAL CORP. |
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX |
08/13/2010 |
K081042 |
BSD MEDICAL SYSTEMS CORP. |
MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES |
09/03/2008 |
K171358 |
Coviden llc |
Emprint SX Ablation Platform and Accessories |
09/01/2017 |
K133821 |
Covidien LLC |
EMPRINT ABLATION SYSTEM |
04/28/2014 |
K163105 |
COVIDIEN LLC |
Emprint Ablation System |
12/06/2016 |
K200796 |
Covidien LLC |
Emprint Ablation System with Thermosphere Technology |
08/26/2020 |
K193232 |
Covidien LLC |
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology |
02/13/2020 |
K072687 |
COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON |
VALLEYLAB MICROWAVE ABLATION GENERATOR |
11/25/2008 |
K203303 |
Covidien, LLC |
Emprint SX Ablation Platform with Thermosphere Technology |
12/17/2020 |
K223138 |
Creo Medical Ltd. |
AB1 Electrosurgical Instrument, Creo Electrosurgical System |
06/26/2023 |
K200298 |
Creo Medical Ltd. |
ABI Instrument, Creo Electrosurgical System |
01/05/2021 |
K221672 |
Creo Medical Ltd. |
Creo Electrosurgical System with NP1 Instrument |
02/14/2023 |
K200003 |
Creo Medical Ltd. |
NP1 Instrument, Creo Electrosurgical System |
10/28/2020 |
K181941 |
Emblation Ltd |
Swift System |
10/18/2018 |
K222388 |
Emblation Ltd. |
swiftPro System |
05/04/2023 |
K072870 |
FOUNDRY NEWCO X, INC. |
MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) |
01/14/2008 |
K200061 |
Galil Medical Inc. |
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) |
07/09/2020 |
K061865 |
GUIDANT CORP. |
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 |
07/27/2006 |
K041340 |
GUIDANT CORPORATION, CARDIAC SURGERY |
GUIDANT MICROWAVE ABLATION SYSTEM |
07/28/2004 |
K083157 |
H.S HOSPITAL SERVICE S.P.A. |
HS AMICA |
09/29/2009 |
K143203 |
MEDWAVES INCORPORATED |
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 |
08/26/2015 |
K070356 |
MEDWAVES INCORPORATED |
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM |
12/18/2007 |
K083537 |
MEDWAVES INCORPORATED |
MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM |
01/15/2009 |
K192406 |
MedWaves, Inc. |
AveCure BT Microwave Ablation System |
11/25/2020 |
K052919 |
MICROSULIS AMERICAS, INC. |
MICROSULIS TISSUE ABLATION SYSTEM |
01/13/2006 |
K122762 |
MICROSULIS MEDICAL LIMITED |
ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR |
11/30/2012 |
K094021 |
MICROSULIS MEDICAL LIMITED |
ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I |
08/06/2010 |
K070023 |
MICROSURGEON, INC. |
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 |
08/15/2007 |
K082565 |
MICROSURGEON, INC. |
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 |
02/12/2009 |
K223272 |
Mima-Pro Scientific Inc. |
SurBlate Ablation System |
02/28/2023 |
K082819 |
MIRAMAR LABS, INC. |
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 |
03/20/2009 |
K160141 |
Miramar Labs, Inc. |
miraDry System |
10/31/2016 |
K180396 |
Miramar Labs, Inc. |
miraDry System |
03/15/2018 |
K201262 |
Nanjing ECO Microwave System Co., Ltd |
Microwave Therapeutic System |
07/09/2021 |
K201265 |
Nanjing ECO Microwave System Co., Ltd. |
Disposable Microwave Therapeutic Antennas |
07/23/2021 |
K220472 |
NeuWave Medical Inc. |
NEUWAVE Microwave Ablation System and Accessories |
08/11/2022 |
K122217 |
NEUWAVE MEDICAL, INC |
CERTUS 140 2.45GHZ ABLATION SYSTEM |
12/19/2012 |
K160936 |
NEUWAVE MEDICAL, INC |
Certus 140 2.45GHz Ablation System |
05/04/2016 |
K100744 |
NEUWAVE MEDICAL, INC |
CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 |
10/22/2010 |
K113237 |
NEUWAVE MEDICAL, INC. |
CERTUS 140 2.45GHZ ABLATION SYSTEM |
01/04/2012 |
K173756 |
NeuWave Medical, Inc. |
Certus 140 2.45GHz Ablation System |
10/24/2018 |
K130399 |
NEUWAVE MEDICAL, INC. |
CERTUS 140 CERTUSURGGT SURGICAL TOOL |
07/18/2013 |
K163118 |
NEUWAVE MEDICAL, INC. |
FLEX Microwave Ablation System and Accessories |
03/09/2017 |
K200081 |
NeuWave Medical, Inc. |
NEUWAVE Microwave Ablation System and Accessories |
11/13/2020 |
K183153 |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
Microwave Ablation System |
07/08/2019 |
K053535 |
VALLEYLAB |
VIVAWAVE MICROWAVE ABLATION SYSTEM |
04/27/2006 |
K011676 |
VIVANT MEDICAL, INC. |
VIVAWAVE MICROWAVE SYSTEM |
06/18/2002 |