Atlas FDA

NEY

68 FDA 510(k) clearances · Product code

150 daysmedian time to decision
334 days90th percentile
68clearances measured

FDA profile

Official device name
System, Ablation, Microwave And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 217 · 2022: 142 · 2023: 106 · 2024: 141 · 2025: 113 · 2026: 59
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
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) (K253771)Nanjing Devin Medical Technology Co., Ltd.2026-03-02
Microwave Ablation Device (K252632)Nanjing Dewen Medical Technology Co., Ltd.2026-03-02
swiftPro System (SWF-SPS); Swift System (SWF-SYS) (K250718)Emblation Limited2025-08-08
Microwave Ablation Generator (KY-2000A, KY-2100A) (K241827)Canyon Medical, Inc.2024-09-26
Microwave Ablation Antennas (K241825)Canyon Medical, Inc.2024-09-20
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) (K240480)Varian Medical Systems, Inc.2024-07-19
Temperature Sensor Probe (ABL-18TP20) (K240784)Varian Medical Systems, Inc.2024-05-29
swiftPro™ System (K240518)Emblation Limited2024-04-23
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) (K233838)Medtronic, Inc.2024-03-28
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) (K233140)Hygea Medical Technology Co., Ltd.2024-01-31
NEUWAVE™ Microwave Ablation System and Accessories (K231738)Neuwave Medical, Inc.2023-11-16
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) (K232241)Betters(Suzhou) Medical Co., Ltd.2023-11-13
Microwave Ablation System (BD-GT) (K232240)Betters(Suzhou) Medical Co., Ltd.2023-11-13
AB1 Electrosurgical Instrument, Creo Electrosurgical System (K223138)Creo Medical, Ltd.2023-06-26
swiftPro System (K222388)Emblation , Ltd.2023-05-04
Solero Microwave Tissue Ablation (MTA) System and Accessories (K223581)AngioDynamics, Inc.2023-03-27
Solero Microwave Tissue Ablation (MTA) System and Accessories (K221883)AngioDynamics, Inc.2023-03-07
SurBlate Ablation System (K223272)Mima-Pro Scientific, Inc.2023-02-28
Creo Electrosurgical System with NP1 Instrument (K221672)Creo Medical, Ltd.2023-02-14
NEUWAVE Microwave Ablation System and Accessories (K220472)Neuwave Medical, Inc.2022-08-11
Solero Microwave Tissue Ablation (MTA) System and Accessories (K213067)AngioDynamics, Inc.2021-12-03
Disposable Microwave Therapeutic Antennas (K201265)Nanjing Eco Microwave System Co., Ltd.2021-07-23
Microwave Therapeutic System (K201262)Nanjing Eco Microwave System Co., Ltd.2021-07-09
ABI Instrument, Creo Electrosurgical System (K200298)Creo Medical, Ltd.2021-01-05
Emprint SX Ablation Platform with Thermosphere Technology (K203303)Covidien, LLC2020-12-17
AveCure BT Microwave Ablation System (K192406)Medwaves, Inc.2020-11-25
NEUWAVE Microwave Ablation System and Accessories (K200081)Neuwave Medical, Inc.2020-11-13
NP1 Instrument, Creo Electrosurgical System (K200003)Creo Medical, Ltd.2020-10-28
Emprint Ablation System with Thermosphere Technology (K200796)Covidien, LLC2020-08-26
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) (K200061)Galil Medical, Inc.2020-07-09
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology (K193232)Covidien, LLC2020-02-13
Microwave Ablation System (K183153)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2019-07-08
Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) (K182250)AngioDynamics, Inc.2019-02-28
Certus 140 2.45GHz Ablation System (K173756)Neuwave Medical, Inc.2018-10-24
Swift System (K181941)Emblation , Ltd.2018-10-18
miraDry System (K180396)Miramar Labs, Inc.2018-03-15
Emprint SX Ablation Platform and Accessories (K171358)Coviden, LLC2017-09-01
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) (K162449)AngioDynamics, Inc.2017-05-05
FLEX Microwave Ablation System and Accessories (K163118)Neuwave Medical, Inc.2017-03-09
Emprint Ablation System (K163105)Covidien, LLC2016-12-06
miraDry System (K160141)Miramar Labs, Inc.2016-10-31
Certus 140 2.45GHz Ablation System (K160936)Neuwave Medical, Inc.2016-05-04
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 (K143203)Medwaves Incorporated2015-08-26
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES (K141785)Bsd Medical Corp.2015-03-31
EMPRINT ABLATION SYSTEM (K133821)Covidien, LLC2014-04-28
CERTUS 140 CERTUSURGGT SURGICAL TOOL (K130399)Neuwave Medical, Inc.2013-07-18
CERTUS 140 2.45GHZ ABLATION SYSTEM (K122217)Neuwave Medical, Inc.2012-12-19
ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR (K122762)Microsulis Medical Limited2012-11-30
CERTUS 140 2.45GHZ ABLATION SYSTEM (K113237)Neuwave Medical, Inc.2012-01-04
CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 (K100744)Neuwave Medical, Inc.2010-10-22
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX (K100786)Bsd Medical Corp.2010-08-13
ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I (K094021)Microsulis Medical Limited2010-08-06
HS AMICA (K083157)H.S Hospital Service S.P.A2009-09-29
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 (K082819)Miramar Labs, Inc.2009-03-20
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 (K082565)Microsurgeon, Inc.2009-02-12
MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM (K083537)Medwaves Incorporated2009-01-15
VALLEYLAB MICROWAVE ABLATION GENERATOR (K072687)Covidien Lp, Formerly Know AS Valleylab, A Divison2008-11-25
MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES (K081042)Bsd Medical Systems Corp.2008-09-03
MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) (K072870)Foundry Newco X, Inc.2008-01-14
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM (K070356)Medwaves Incorporated2007-12-18
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 (K070023)Microsurgeon, Inc.2007-08-15
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 (K061865)Guidant Corp.2006-07-27
VIVAWAVE MICROWAVE ABLATION SYSTEM (K053535)Valleylab2006-04-27
MICROSULIS TISSUE ABLATION SYSTEM (K052919)Microsulis Americas, Inc.2006-01-13
GUIDANT MICROWAVE ABLATION SYSTEM (K041340)Guidant Corporation, Cardiac Surgery2004-07-28
VIVAWAVE MICROWAVE SYSTEM (K011676)Vivant Medical, Inc.2002-06-18
FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM (K013946)Afx, Inc.2002-02-27
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 (K003978)Afx, Inc.2001-05-22

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Every clearance here is in the API, with alerts when new ones post.