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FDA 510(k)

MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES

K-Number: K081042 · 2008-09-03

ApplicantBsd Medical Systems Corp.
Decision Date2008-09-03
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Bsd Medical Systems Corp.. It received FDA 510(k) clearance on 2008-09-03 under 510(k) number K081042. 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 MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES?

MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2008-09-03. The listed applicant is Bsd Medical Systems Corp.. The 510(k) number is K081042.

When did MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2008-09-03, under 510(k) number K081042.

Who is the listed applicant for MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES?

The FDA 510(k) record lists Bsd Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES?

The FDA product code for MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES is NEY.

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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.

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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