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FDA 510(k)

Microwave Therapeutic System

K-Number: K201262 · 2021-07-09

ApplicantNanjing Eco Microwave System Co., Ltd.
Decision Date2021-07-09
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Microwave Therapeutic System is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Eco Microwave System Co., Ltd.. It received FDA 510(k) clearance on 2021-07-09 under 510(k) number K201262. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Microwave Therapeutic System?

Microwave Therapeutic System is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Nanjing Eco Microwave System Co., Ltd.. The 510(k) number is K201262.

When did Microwave Therapeutic System receive FDA 510(k) clearance?

Microwave Therapeutic System received FDA 510(k) clearance on 2021-07-09, under 510(k) number K201262.

Who is the listed applicant for Microwave Therapeutic System?

The FDA 510(k) record lists Nanjing Eco Microwave System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microwave Therapeutic System?

The FDA product code for Microwave Therapeutic System is NEY.

Other records listing Nanjing Eco Microwave System Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201265Disposable Microwave Therapeutic Antennas

Related Devices (Code: NEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation LimitedK241827Microwave 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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