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FDA 510(k)

VALLEYLAB MICROWAVE ABLATION GENERATOR

K-Number: K072687 · 2008-11-25

ApplicantCovidien Lp, Formerly Know AS Valleylab, A Divison
Decision Date2008-11-25
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VALLEYLAB MICROWAVE ABLATION GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Covidien Lp, Formerly Know AS Valleylab, A Divison. It received FDA 510(k) clearance on 2008-11-25 under 510(k) number K072687. 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 VALLEYLAB MICROWAVE ABLATION GENERATOR?

VALLEYLAB MICROWAVE ABLATION GENERATOR is a medical device that received FDA 510(k) clearance on 2008-11-25. The listed applicant is Covidien Lp, Formerly Know AS Valleylab, A Divison. The 510(k) number is K072687.

When did VALLEYLAB MICROWAVE ABLATION GENERATOR receive FDA 510(k) clearance?

VALLEYLAB MICROWAVE ABLATION GENERATOR received FDA 510(k) clearance on 2008-11-25, under 510(k) number K072687.

Who is the listed applicant for VALLEYLAB MICROWAVE ABLATION GENERATOR?

The FDA 510(k) record lists Covidien Lp, Formerly Know AS Valleylab, A Divison as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALLEYLAB MICROWAVE ABLATION GENERATOR?

The FDA product code for VALLEYLAB MICROWAVE ABLATION GENERATOR 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.

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Other records listing Covidien Lp, Formerly Know AS Valleylab, A Divison 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.

K110268FORCETRIAD ELECTROSURGICAL GENERATOR

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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