System, Ablation, Microwave And Accessories

FDA product code NEY · 65 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4400
Review panel: SU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 2001-05-22 – 2026-03-02

NEY 2026-03-02

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)

Applicant Nanjing Devin Medical Technology Co., Ltd.

K number K253771

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NEY 2026-03-02

Microwave Ablation Device

Applicant Nanjing Dewen Medical Technology Co., Ltd.

K number K252632

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NEY 2025-08-08

swiftPro System (SWF-SPS); Swift System (SWF-SYS)

Applicant Emblation Limited

K number K250718

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NEY 2024-09-26

Microwave Ablation Generator (KY-2000A, KY-2100A)

Applicant Canyon Medical, Inc.

K number K241827

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NEY 2024-09-20

Microwave Ablation Antennas

Applicant Canyon Medical, Inc.

K number K241825

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NEY 2024-07-19

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)

Applicant Varian Medical Systems, Inc.

K number K240480

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NEY 2024-05-29

Temperature Sensor Probe (ABL-18TP20)

Applicant Varian Medical Systems, Inc.

K number K240784

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NEY 2024-04-23

swiftPro™ System

Applicant Emblation Limited

K number K240518

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NEY 2024-03-28

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)

Applicant Medtronic, Inc.

K number K233838

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NEY 2024-01-31

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)

Applicant Hygea Medical Technology Co., Ltd.

K number K233140

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NEY 2023-11-16

NEUWAVE™ Microwave Ablation System and Accessories

Applicant Neuwave Medical, Inc.

K number K231738

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NEY 2023-11-13

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)

Applicant Betters(Suzhou) Medical Co., Ltd.

K number K232241

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NEY 2023-11-13

Microwave Ablation System (BD-GT)

Applicant Betters(Suzhou) Medical Co., Ltd.

K number K232240

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NEY 2023-06-26

AB1 Electrosurgical Instrument, Creo Electrosurgical System

Applicant Creo Medical, Ltd.

K number K223138

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NEY 2023-05-04

swiftPro System

Applicant Emblation , Ltd.

K number K222388

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NEY 2023-03-27

Solero Microwave Tissue Ablation (MTA) System and Accessories

Applicant AngioDynamics, Inc.

K number K223581

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NEY 2023-03-07

Solero Microwave Tissue Ablation (MTA) System and Accessories

Applicant AngioDynamics, Inc.

K number K221883

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NEY 2023-02-28

SurBlate Ablation System

Applicant Mima-Pro Scientific, Inc.

K number K223272

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NEY 2023-02-14

Creo Electrosurgical System with NP1 Instrument

Applicant Creo Medical, Ltd.

K number K221672

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NEY 2022-08-11

NEUWAVE Microwave Ablation System and Accessories

Applicant Neuwave Medical, Inc.

K number K220472

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NEY 2021-12-03

Solero Microwave Tissue Ablation (MTA) System and Accessories

Applicant AngioDynamics, Inc.

K number K213067

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NEY 2021-07-23

Disposable Microwave Therapeutic Antennas

Applicant Nanjing Eco Microwave System Co., Ltd.

K number K201265

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NEY 2021-07-09

Microwave Therapeutic System

Applicant Nanjing Eco Microwave System Co., Ltd.

K number K201262

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NEY 2021-01-05

ABI Instrument, Creo Electrosurgical System

Applicant Creo Medical, Ltd.

K number K200298

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NEY 2020-12-17

Emprint SX Ablation Platform with Thermosphere Technology

Applicant Covidien, LLC

K number K203303

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NEY 2020-11-25

AveCure BT Microwave Ablation System

Applicant Medwaves, Inc.

K number K192406

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NEY 2020-11-13

NEUWAVE Microwave Ablation System and Accessories

Applicant Neuwave Medical, Inc.

K number K200081

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NEY 2020-10-28

NP1 Instrument, Creo Electrosurgical System

Applicant Creo Medical, Ltd.

K number K200003

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NEY 2020-08-26

Emprint Ablation System with Thermosphere Technology

Applicant Covidien, LLC

K number K200796

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NEY 2020-07-09

HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)

Applicant Galil Medical, Inc.

K number K200061

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NEY 2020-02-13

Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology

Applicant Covidien, LLC

K number K193232

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NEY 2019-07-08

Microwave Ablation System

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K number K183153

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NEY 2019-02-28

Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)

Applicant AngioDynamics, Inc.

K number K182250

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NEY 2018-10-24

Certus 140 2.45GHz Ablation System

Applicant Neuwave Medical, Inc.

K number K173756

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NEY 2018-10-18

Swift System

Applicant Emblation , Ltd.

K number K181941

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NEY 2018-03-15

miraDry System

Applicant Miramar Labs, Inc.

K number K180396

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NEY 2017-09-01

Emprint SX Ablation Platform and Accessories

Applicant Coviden, LLC

K number K171358

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NEY 2017-05-05

Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)

Applicant AngioDynamics, Inc.

K number K162449

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NEY 2017-03-09

FLEX Microwave Ablation System and Accessories

Applicant Neuwave Medical, Inc.

K number K163118

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NEY 2016-12-06

Emprint Ablation System

Applicant Covidien, LLC

K number K163105

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NEY 2016-10-31

miraDry System

Applicant Miramar Labs, Inc.

K number K160141

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NEY 2016-05-04

Certus 140 2.45GHz Ablation System

Applicant Neuwave Medical, Inc.

K number K160936

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NEY 2013-07-18

CERTUS 140 CERTUSURGGT SURGICAL TOOL

Applicant Neuwave Medical, Inc.

K number K130399

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NEY 2012-12-19

CERTUS 140 2.45GHZ ABLATION SYSTEM

Applicant Neuwave Medical, Inc.

K number K122217

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NEY 2012-11-30

ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR

Applicant Microsulis Medical Limited

K number K122762

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NEY 2012-01-04

CERTUS 140 2.45GHZ ABLATION SYSTEM

Applicant Neuwave Medical, Inc.

K number K113237

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NEY 2010-10-22

CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140

Applicant Neuwave Medical, Inc.

K number K100744

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NEY 2010-08-13

MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX

Applicant Bsd Medical Corp.

K number K100786

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NEY 2010-08-06

ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I

Applicant Microsulis Medical Limited

K number K094021

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NEY 2009-09-29

HS AMICA

Applicant H.S Hospital Service S.P.A

K number K083157

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NEY 2009-03-20

DERMATOLOGIC TREATMENT SYSTEM (DTS) G2

Applicant Miramar Labs, Inc.

K number K082819

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NEY 2009-02-12

MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200

Applicant Microsurgeon, Inc.

K number K082565

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NEY 2009-01-15

MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM

Applicant Medwaves Incorporated

K number K083537

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NEY 2008-11-25

VALLEYLAB MICROWAVE ABLATION GENERATOR

Applicant Covidien Lp, Formerly Know AS Valleylab, A Divison

K number K072687

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NEY 2008-09-03

MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES

Applicant Bsd Medical Systems Corp.

K number K081042

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NEY 2008-01-14

MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)

Applicant Foundry Newco X, Inc.

K number K072870

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NEY 2007-12-18

MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM

Applicant Medwaves Incorporated

K number K070356

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NEY 2007-08-15

MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100

Applicant Microsurgeon, Inc.

K number K070023

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NEY 2006-07-27

FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05

Applicant Guidant Corp.

K number K061865

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NEY 2006-04-27

VIVAWAVE MICROWAVE ABLATION SYSTEM

Applicant Valleylab

K number K053535

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NEY 2006-01-13

MICROSULIS TISSUE ABLATION SYSTEM

Applicant Microsulis Americas, Inc.

K number K052919

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NEY 2004-07-28

GUIDANT MICROWAVE ABLATION SYSTEM

Applicant Guidant Corporation, Cardiac Surgery

K number K041340

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NEY 2002-06-18

VIVAWAVE MICROWAVE SYSTEM

Applicant Vivant Medical, Inc.

K number K011676

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NEY 2002-02-27

FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM

Applicant Afx, Inc.

K number K013946

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NEY 2001-05-22

AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007

Applicant Afx, Inc.

K number K003978

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