FDA.reportPublic FDA data

ECO Disposable microwave therapeutic antenna

Primary DI
06972405777112
Brand
ECO Disposable microwave therapeutic antenna
Company
ECO Medical Technology (Nanjing) Co., Ltd.
Model
ECO-100AI30
Device description
Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable without cooling tubes.
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
Sterile
true
Single use
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
K201265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201265000Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.2021-07-23NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972405777112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972405777112069724057771126972405777112

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system probeA hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours and/or hydatid cysts. The probe includes a handle and an antenna, and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic (e.g., gastroscopic, laparoscopic), and open surgery procedures to ablate tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
546257098
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972405777006SABERWAVE/ECO Microwave therapeutic systemSABERWAVE ECO-200G2022-11-02
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
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

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Primary DI, Brand, Company table
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