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FDA 510(k)

NEUWAVE Microwave Ablation System and Accessories

K-Number: K200081 · 2020-11-13

ApplicantNeuwave Medical, Inc.
Decision Date2020-11-13
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEUWAVE Microwave Ablation System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K200081. 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 NEUWAVE Microwave Ablation System and Accessories?

NEUWAVE Microwave Ablation System and Accessories is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Neuwave Medical, Inc.. The 510(k) number is K200081.

When did NEUWAVE Microwave Ablation System and Accessories receive FDA 510(k) clearance?

NEUWAVE Microwave Ablation System and Accessories received FDA 510(k) clearance on 2020-11-13, under 510(k) number K200081.

Who is the listed applicant for NEUWAVE Microwave Ablation System and Accessories?

The FDA 510(k) record lists Neuwave Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUWAVE Microwave Ablation System and Accessories?

The FDA product code for NEUWAVE Microwave Ablation System and Accessories is NEY.

Related Clinical Trials

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.

NCT04107766NOLA (NeuWave Observational Liver Ablation) RegistryTERMINATED

Other records listing Neuwave Medical, Inc. 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.

K232227ABLATE-IQK231738NEUWAVE™ Microwave Ablation System and AccessoriesK220472NEUWAVE Microwave Ablation System and AccessoriesK192427Ablation ConfirmationK173756Certus 140 2.45GHz Ablation SystemK171022Ablation Confirmation

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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

View on FDA Database →

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

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