System, Ablation, Microwave And Accessories

Product Code: NEY

General & Plastic Surgery Microwave Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4400


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as NEY

5765System, Ablation, Microwave And AccessoriesElectrosurgical Cutting And Coagulation Device And Accessories.

Total Product Life Cycle (TPLC) Devices

5765System, Ablation, Microwave And AccessoriesElectrosurgical Cutting And Coagulation Device And Accessories.

Pre-market Notifications for NEY

K220472NEUWAVE Microwave Ablation System And AccessoriesNeuWave Medical Inc.
K213067Solero Microwave Tissue Ablation (MTA) System And AccessoriesAngioDynamics, Inc.
K203303Emprint SX Ablation Platform With Thermosphere TechnologyCovidien, LLC
K201265Disposable Microwave Therapeutic AntennasNanjing ECO Microwave System Co., Ltd.
K201262Microwave Therapeutic SystemNanjing ECO Microwave System Co., Ltd
K200796Emprint Ablation System With Thermosphere TechnologyCovidien LLC
K200081NEUWAVE Microwave Ablation System And AccessoriesNeuWave Medical, Inc.
K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)Galil Medical Inc.
K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical Ltd.
K193232Emprint Ablation System With Thermosphere Technology, Emprint SX Ablation Platform With Thermosphere TechnologyCovidien LLC
K192406AveCure BT Microwave Ablation SystemMedWaves, Inc.
K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
K182250Solero MTA Cart, Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), , Solero Microwave Tissue Ablation Applicator (19cm), Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc.
K181941Swift SystemEmblation Ltd
K180396MiraDry SystemMiramar Labs, Inc.

Global Unique Device Identification Database

00853719006302SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
00858584002220System, Ablation, Microwave And Accessories
00858584002213System, Ablation, Microwave And Accessories
00858584002206System, Ablation, Microwave And Accessories
00858584002190System, Ablation, Microwave And Accessories
00858584002183System, Ablation, Microwave And Accessories
00858584002176System, Ablation, Microwave And Accessories
00858584002169System, Ablation, Microwave And Accessories
00858584002152System, Ablation, Microwave And Accessories
00858584002145System, Ablation, Microwave And Accessories
00858584002138System, Ablation, Microwave And Accessories
00858584002114System, Ablation, Microwave And Accessories
00858584002091System, Ablation, Microwave And Accessories
00858584002084System, Ablation, Microwave And Accessories
00858584002077System, Ablation, Microwave And Accessories

Maude Adverse Events

EMPRINTCOVIDIEN MEDICAL PRODUCTS2020-03-25
NEUWAVE ABLATORETHICON/NEUWAVE MEDICAL, INC.2020-03-20
NEUWAVE PR XT PROBE 20CM 15GANEUWAVE MEDICAL, INC.2020-03-17
EMPRINTCOVIDIEN LP - SUPERDIMENSION INC2020-03-17
NEUWAVE LK PROBE 20CM 17GANEUWAVE MEDICAL, INC.2020-03-13
NW ABLATION SYSTEM, USNEUWAVE MEDICAL, INC.2020-03-12
SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM)ANGIODYNAMICS2020-03-09
SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM)ANGIODYNAMICS2020-03-09
EMPRINTCOVIDIEN LP - SUPERDIMENSION INC2020-03-04
EMPRINTCOVIDIEN MEDICAL PRODUCTS2020-03-02
EMPRINTCOVIDIEN MEDICAL PRODUCTS2020-02-21
EMPRINTCOVIDIEN MEDICAL PRODUCTS2020-02-21
EMPRINTCOVIDIEN MEDICAL PRODUCTS2020-02-19
SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM)ANGIODYNAMICS2020-02-12
NEUWAVE PR XT PROBE 20CM 15GANEUWAVE MEDICAL, INC.2020-02-10
EMPRINTCOVIDIEN LP - SUPERDIMENSION INC2020-02-06
EMPRINTCOVIDIEN MEDICAL PRODUCTS2020-01-30
SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM)ANGIODYNAMICS2020-01-22
H. S. MEDICAL INC. AMICA MICROWAVE ABLATION PROBEH. S. HOSPITAL SERVICES S. P. A.2020-01-10
EMPRINTCOVIDIEN MEDICAL PRODUCTS2020-01-10
NEUWAVE PR PROBE 15CM 17GANEUWAVE MEDICAL, INC.2020-01-09
NEUWAVE MEDICAL INTELLIGENT ABLATION PR 15CMNEUWAVE MEDICAL2020-01-09
EMPRINTCOVIDIEN MEDICAL PRODUCTS2020-01-09
EMPRINTCOVIDIEN MEDICAL PRODUCTS2020-01-07
UNKNOWN EMPRINT ANTENNACOVIDIEN LP - SUPERDIMENSION INC2020-01-07
EMPRINTCOVIDIEN LP - SUPERDIMENSION INC2020-01-06
UNKNOWN_NEUWAVENEUWAVE MEDICAL, INC.2019-12-20
UNKNOWN_NEUWAVENEUWAVE MEDICAL, INC.2019-12-20
UNKNOWN_NEUWAVENEUWAVE MEDICAL, INC.2019-12-20
EMPRINTCOVIDIEN LP - SUPERDIMENSION INC2019-12-17
EMPRINTCOVIDIEN LP - SUPERDIMENSION INC2019-12-17
NEUWAVE PR XT PROBE 15CM 15GANEUWAVE MEDICAL, INC.2019-12-16
EMPRINTCOVIDIEN MEDICAL PRODUCTS2019-12-11
UNKNOWN EMPRINT GENERATORCOVIDIEN LP - SUPERDIMENSION INC2019-11-27
NEUWAVE LK PROBE 15CM 17GANEUWAVE MEDICAL, INC.2019-11-22
SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (29CM)ANGIODYNAMICS2019-11-21
EMPRINTCOVIDIEN LP2019-11-20
EMPRINTCOVIDIEN MEDICAL PRODUCTS2019-11-18
EMPRINTCOVIDIEN MEDICAL PRODUCTS2019-11-13
SOLERO MICROWAVE TISSUE ABLATION SYSTEMANGIODYNAMICS2019-11-05
EMPRINTCOVIDIEN MEDICAL PRODUCTS2019-11-04
NEUWAVE PR PROBE 15CM 17GANEUWAVE MEDICAL, INC.2019-11-02
EMPRINTCOVIDIEN MEDICAL PRODUCTS2019-11-01
SOLERO MICROWAVE TISSUE ABLATION SYSTEMANGIODYNAMICS2019-11-01
UNKNOWN EMPRINT GENERATORCOVIDIEN LP - SUPERDIMENSION INC2019-10-30
SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM)ANGIODYNAMICS2019-10-30
EVIDENTCOVIDIEN LP - SUPERDIMENSION INC2019-10-29
NEUWAVE PR XT PROBE 15CM 15GANEUWAVE MEDICAL, INC.2019-10-29
NEUWAVE PR XT PROBE 15CM 15GANEUWAVE MEDICAL, INC.2019-10-29
SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM)ANGIODYNAMICS2019-10-28
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