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FDA 510(k)

MICROSULIS TISSUE ABLATION SYSTEM

K-Number: K052919 · 2006-01-13

ApplicantMicrosulis Americas, Inc.
Decision Date2006-01-13
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROSULIS TISSUE ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Microsulis Americas, Inc.. It received FDA 510(k) clearance on 2006-01-13 under 510(k) number K052919. 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 MICROSULIS TISSUE ABLATION SYSTEM?

MICROSULIS TISSUE ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-13. The listed applicant is Microsulis Americas, Inc.. The 510(k) number is K052919.

When did MICROSULIS TISSUE ABLATION SYSTEM receive FDA 510(k) clearance?

MICROSULIS TISSUE ABLATION SYSTEM received FDA 510(k) clearance on 2006-01-13, under 510(k) number K052919.

Who is the listed applicant for MICROSULIS TISSUE ABLATION SYSTEM?

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

What is the FDA product code for MICROSULIS TISSUE ABLATION SYSTEM?

The FDA product code for MICROSULIS TISSUE ABLATION SYSTEM 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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