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FDA 510(k)

swiftPro System (SWF-SPS); Swift System (SWF-SYS)

K-Number: K250718 · 2025-08-08

ApplicantEmblation Limited
Decision Date2025-08-08
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

swiftPro System (SWF-SPS); Swift System (SWF-SYS) is the device name listed in this FDA 510(k) record. The listed applicant is Emblation Limited. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K250718. 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 swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

swiftPro System (SWF-SPS); Swift System (SWF-SYS) is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Emblation Limited. The 510(k) number is K250718.

When did swiftPro System (SWF-SPS); Swift System (SWF-SYS) receive FDA 510(k) clearance?

swiftPro System (SWF-SPS); Swift System (SWF-SYS) received FDA 510(k) clearance on 2025-08-08, under 510(k) number K250718.

Who is the listed applicant for swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

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

What is the FDA product code for swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

The FDA product code for swiftPro System (SWF-SPS); Swift System (SWF-SYS) is NEY.

Other records listing Emblation 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.

K240518swiftPro™ SystemK222388swiftPro SystemK181941Swift System

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.K241827Microwave 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.K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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