FDA 510(k)

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

Numéro K : K233140 · 2024-01-31

DemandeurHygea Medical Technology Co., Ltd.

Date de décision2024-01-31

Code produitNEY

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is the device name listed in this FDA 510(k) record. The listed applicant is Hygea Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-31 under 510(k) number K233140. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)?

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is a medical device that received FDA 510(k) clearance on 2024-01-31. The listed applicant is Hygea Medical Technology Co., Ltd.. The 510(k) number is K233140.

When did Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) receive FDA 510(k) clearance?

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) received FDA 510(k) clearance on 2024-01-31, under 510(k) number K233140.

Who is the listed applicant for Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)?

The FDA 510(k) record lists Hygea Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)?

The FDA product code for Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is NEY.

Essais cliniques associés

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Autres dossiers indiquant Hygea Medical Technology Co., Ltd. en tant que demandeur

K243042Co-Ablation System with Sterile Co-Ablation Probe

Dispositifs connexes (Code : NEY)

K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.K253771Disposable 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)Nanjing Devin Medical Technology Co., Ltd.K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.K241825Microwave Ablation AntennasCanyon Medical, Inc.K240480IntelliBlate 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)Varian Medical Systems, Inc.

Source officielle

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