FDA.reportPublic FDA data

SABERWAVE/ECO Microwave therapeutic system

Primary DI
06972405777006
Brand
SABERWAVE/ECO Microwave therapeutic system
Company
ECO Medical Technology (Nanjing) Co., Ltd.
Model
SABERWAVE ECO-200G
Device description
The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that deliver the microwave energy at a working frequency of 2450 MHz.
Published
2022-11-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NEYSystem, Ablation, Microwave And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201262000Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.2021-07-09NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972405777006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972405777006069724057770066972405777006

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system generatorA mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours and/or hydatid cysts. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, or open surgery procedures to ablate tissue typically in the liver, lung, pancreas and kidney.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
546257098
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972405777013ECO Disposable microwave therapeutic antennaECO-100CL28C2022-11-02
06972405777020ECO Disposable microwave therapeutic antennaECO-100CL27C2022-11-02
06972405777037ECO Disposable microwave therapeutic antennaECO-100AI262022-11-02
06972405777044ECO Disposable microwave therapeutic antennaECO-100AI12022-11-02
06972405777051ECO Disposable microwave therapeutic antennaECO-100CL22C2022-11-02
06972405777068ECO Disposable microwave therapeutic antennaECO-100CL52022-11-02
06972405777075ECO Disposable microwave therapeutic antennaECO-100CL5C2022-11-02
06972405777082ECO Disposable microwave therapeutic antennaECO-100AI32022-11-02
06972405777099ECO Disposable microwave therapeutic antennaECO-100AL23C2022-11-02
06972405777105ECO Disposable microwave therapeutic antennaECO-100AL13C2022-11-02
06972405777112ECO Disposable microwave therapeutic antennaECO-100AI302022-11-02
06972405777129ECO Disposable microwave therapeutic antennaECO-100AL292022-11-02
06972405777136ECO Disposable microwave therapeutic antennaECO-100CL292022-11-02
06972405777143ECO Disposable microwave therapeutic antennaECO-100CL11C2022-11-02
06972405777150ECO Disposable microwave therapeutic antennaECO-100CL102022-11-02
06972405777167ECO Disposable microwave therapeutic antennaECO-100CL10C2022-11-02
06972405777174ECO Disposable microwave therapeutic antennaECO-100CL82022-11-02
06972405777181ECO Disposable microwave therapeutic antennaECO-100CL8C2022-11-02
06972405777198ECO Disposable microwave therapeutic antennaECO-100AI18C2022-11-02
06972405777204ECO Disposable microwave therapeutic antennaECO-100CL312022-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935650621319HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621333HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621357HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621371HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622613HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622620HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622637HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622651HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622668HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622682HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622699HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622729HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623344HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623351HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650624327HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626048HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626451HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626468HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
05060359560971MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
05060359560490MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
06954414601015Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601022Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601039Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601046Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601053Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601060Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601077Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601084Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601107Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601121Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14