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FDA 510(k)

ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR

K-Number: K122762 · 2012-11-30

ApplicantMicrosulis Medical Limited
Decision Date2012-11-30
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Microsulis Medical Limited. It received FDA 510(k) clearance on 2012-11-30 under 510(k) number K122762. 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 ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR?

ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR is a medical device that received FDA 510(k) clearance on 2012-11-30. The listed applicant is Microsulis Medical Limited. The 510(k) number is K122762.

When did ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR receive FDA 510(k) clearance?

ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR received FDA 510(k) clearance on 2012-11-30, under 510(k) number K122762.

Who is the listed applicant for ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR?

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

What is the FDA product code for ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR?

The FDA product code for ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR 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 Microsulis Medical Limited 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.

K094021ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I

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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