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FDA 510(k)

MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM

K-Number: K070356 · 2007-12-18

ApplicantMedwaves Incorporated
Decision Date2007-12-18
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medwaves Incorporated. It received FDA 510(k) clearance on 2007-12-18 under 510(k) number K070356. 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 MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM?

MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-12-18. The listed applicant is Medwaves Incorporated. The 510(k) number is K070356.

When did MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM receive FDA 510(k) clearance?

MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM received FDA 510(k) clearance on 2007-12-18, under 510(k) number K070356.

Who is the listed applicant for MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM?

The FDA 510(k) record lists Medwaves Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM?

The FDA product code for MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medwaves Incorporated 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.

K083537MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM

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.

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 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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