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FDA 510(k)

FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM

K-Number: K013946 · 2002-02-27

ApplicantAfx, Inc.
Decision Date2002-02-27
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Afx, Inc.. It received FDA 510(k) clearance on 2002-02-27 under 510(k) number K013946. 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 FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM?

FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-27. The listed applicant is Afx, Inc.. The 510(k) number is K013946.

When did FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM receive FDA 510(k) clearance?

FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM received FDA 510(k) clearance on 2002-02-27, under 510(k) number K013946.

Who is the listed applicant for FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM?

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

What is the FDA product code for FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM?

The FDA product code for FLEX 10 ACCESSORY FOR THE AFX MICROWAVE 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 Afx, 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.

K003978AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007

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

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