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Panels › General, Plastic Surgery › Product code NEY · Class 2

System, Ablation, Microwave And Accessories

Regulation 878.4400

2510(k)s in 12 months (68 all time)
0recalls in 12 months (27 all time)
25recalls that name a 510(k)
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Top companies in NEY

Company510(k)sRecalls
Covidien, LLC511
AngioDynamics, Inc.510
Neuwave Medical, Inc.100
Angiodynamics Inc. (Navilyst Medical Inc.)05
Creo Medical, Ltd.40
Emblation , Ltd.40
Medwaves Incorporated40
Miramar Labs, Inc.30
Afx, Inc.20
Betters(Suzhou) Medical Co., Ltd.20
Decided510(k)Device and applicantCode
Mar 2, 2026K253771Disposable 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-
Nanjing Devin Medical Technology Co., Ltd., CN
NEY
Mar 2, 2026K252632Microwave Ablation Device
Nanjing Dewen Medical Technology Co., Ltd., CN
NEY
Aug 8, 2025K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)
Emblation Limited, GB
NEY
Sep 26, 2024K241827Microwave Ablation Generator (KY-2000A, KY-2100A)
Canyon Medical, Inc., CN
NEY
Sep 20, 2024K241825Microwave Ablation Antennas
Canyon Medical, Inc., CN
NEY
Jul 19, 2024K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); I
Varian Medical Systems, Inc.
NEY
May 29, 2024K240784Temperature Sensor Probe (ABL-18TP20)
Varian Medical Systems, Inc.
NEY
Apr 23, 2024K240518swiftPro™ System
Emblation Limited, GB
NEY
Mar 28, 2024K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint
Medtronic, Inc.
NEY
Jan 31, 2024K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
Hygea Medical Technology Co., Ltd., CN
NEY
Nov 16, 2023K231738NEUWAVE™ Microwave Ablation System and Accessories
Neuwave Medical, Inc.
NEY
Nov 13, 2023K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
Betters(Suzhou) Medical Co., Ltd., CN
NEY
Nov 13, 2023K232240Microwave Ablation System (BD-GT)
Betters(Suzhou) Medical Co., Ltd., CN
NEY
Jun 26, 2023K223138AB1 Electrosurgical Instrument, Creo Electrosurgical System
Creo Medical, Ltd., UA
NEY
May 4, 2023K222388swiftPro System
Emblation , Ltd., GB
NEY
Mar 27, 2023K223581Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc.
NEY
Mar 7, 2023K221883Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc.
NEY
Feb 28, 2023K223272SurBlate Ablation System
Mima-Pro Scientific, Inc., CA
NEY
Feb 14, 2023K221672Creo Electrosurgical System with NP1 Instrument
Creo Medical, Ltd., GB
NEY
Aug 11, 2022K220472NEUWAVE Microwave Ablation System and Accessories
Neuwave Medical, Inc.
NEY
Dec 3, 2021K213067Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc.
NEY
Jul 23, 2021K201265Disposable Microwave Therapeutic Antennas
Nanjing Eco Microwave System Co., Ltd., CN
NEY
Jul 9, 2021K201262Microwave Therapeutic System
Nanjing Eco Microwave System Co., Ltd., CN
NEY
Jan 5, 2021K200298ABI Instrument, Creo Electrosurgical System
Creo Medical, Ltd., GB
NEY
Dec 17, 2020K203303Emprint SX Ablation Platform with Thermosphere Technology
Covidien, LLC
NEY
Nov 25, 2020K192406AveCure BT Microwave Ablation System
Medwaves, Inc.
NEY
Nov 13, 2020K200081NEUWAVE Microwave Ablation System and Accessories
Neuwave Medical, Inc.
NEY
Oct 28, 2020K200003NP1 Instrument, Creo Electrosurgical System
Creo Medical, Ltd., GB
NEY
Aug 26, 2020K200796Emprint Ablation System with Thermosphere Technology
Covidien, LLC
NEY
Jul 9, 2020K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-P
Galil Medical, Inc.
NEY
Feb 13, 2020K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
Covidien, LLC
NEY
Jul 8, 2019K183153Microwave Ablation System
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., CN
NEY
Feb 28, 2019K182250Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablati
AngioDynamics, Inc.
NEY
Oct 24, 2018K173756Certus 140 2.45GHz Ablation System
Neuwave Medical, Inc.
NEY
Oct 18, 2018K181941Swift System
Emblation , Ltd., GB
NEY
Mar 15, 2018K180396miraDry System
Miramar Labs, Inc.
NEY
Sep 1, 2017K171358Emprint SX Ablation Platform and Accessories
Coviden, LLC
NEY
May 5, 2017K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm
AngioDynamics, Inc.
NEY
Mar 9, 2017K163118FLEX Microwave Ablation System and Accessories
Neuwave Medical, Inc.
NEY
Dec 6, 2016K163105Emprint Ablation System
Covidien, LLC
NEY
Oct 31, 2016K160141miraDry System
Miramar Labs, Inc.
NEY
May 4, 2016K160936Certus 140 2.45GHz Ablation System
Neuwave Medical, Inc.
NEY
Aug 26, 2015K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenn
Medwaves Incorporated
NEY
Mar 31, 2015K141785MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
Bsd Medical Corp.
NEY
Apr 28, 2014K133821EMPRINT ABLATION SYSTEM
Covidien, LLC
NEY
Jul 18, 2013K130399CERTUS 140 CERTUSURGGT SURGICAL TOOL
Neuwave Medical, Inc.
NEY
Dec 19, 2012K122217CERTUS 140 2.45GHZ ABLATION SYSTEM
Neuwave Medical, Inc.
NEY
Nov 30, 2012K122762ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
Microsulis Medical Limited, GB
NEY
Jan 4, 2012K113237CERTUS 140 2.45GHZ ABLATION SYSTEM
Neuwave Medical, Inc.
NEY
Oct 22, 2010K100744CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140
Neuwave Medical, Inc.
NEY

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