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FDA 510(k)

Microwave Ablation Generator (KY-2000A, KY-2100A)

K-Number: K241827 · 2024-09-26

ApplicantCanyon Medical, Inc.
Decision Date2024-09-26
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Microwave Ablation Generator (KY-2000A, KY-2100A) is the device name listed in this FDA 510(k) record. The listed applicant is Canyon Medical, Inc.. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241827. 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 Microwave Ablation Generator (KY-2000A, KY-2100A)?

Microwave Ablation Generator (KY-2000A, KY-2100A) is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Canyon Medical, Inc.. The 510(k) number is K241827.

When did Microwave Ablation Generator (KY-2000A, KY-2100A) receive FDA 510(k) clearance?

Microwave Ablation Generator (KY-2000A, KY-2100A) received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241827.

Who is the listed applicant for Microwave Ablation Generator (KY-2000A, KY-2100A)?

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

What is the FDA product code for Microwave Ablation Generator (KY-2000A, KY-2100A)?

The FDA product code for Microwave Ablation Generator (KY-2000A, KY-2100A) 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.

NCT06086002Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular CarcinomaCOMPLETEDNCT06426992Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic MalignanciesRECRUITING

Other records listing Canyon Medical, 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.

K250209Polyvinyl Alcohol Embolic MicrospheresK241825Microwave Ablation AntennasK233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy NeedleK222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

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.

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.K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation LimitedK241825Microwave 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.K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.

Official Source

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