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510(k) Data Aggregation
K Number
K232241Device Name
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
Manufacturer
Betters(Suzhou) Medical Co., Ltd
Date Cleared
2023-11-13
(108 days)
Product Code
NEY
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Betters(Suzhou) Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Microwave Ablation Needle is used with the Microwave Ablation System. which is indicated for the ablation of soft tissue during open procedures. The Disposable Microwave Ablation Needle is not intended for cardiac use.
Device Description
Disposable Microwave Ablation Needle is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip.
The Disposable Microwave Ablation Needle is composed of an inlet pipe, an outlet pipe, a handle, a needle rod, a medium tube, a radiation pole, and a coaxial transmission cable. It is a sterile disposable product. The coaxial transmission cable connect the Microwave Ablation System to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operation of the operator.
The Disposable Microwave Ablation Needle is provided sterile, for single use.
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