swiftPro™ System

FDA 510(k) K240518 · Emblation Limited

Substantially Equivalent

510(k) numberK240518

Submission

Device name
swiftPro™ System
Applicant
Emblation Limited
Stirling, GB
Received
February 23, 2024
Decision date
April 23, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NEY – System, Ablation, Microwave And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Specialty
General, Plastic Surgery

Other 510(k)s with product code NEY

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K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…NEY · Traditional Nanjing Devin Medical Technology Co., Ltd.03/02/2026SE
K252632Microwave Ablation DeviceNEY · Traditional Nanjing Dewen Medical Technology Co., Ltd.03/02/2026SE
K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)NEY · Traditional Emblation Limited08/08/2025SE
K241827Microwave Ablation Generator (KY-2000A, KY-2100A)NEY · Traditional Canyon Medical, Inc.09/26/2024SE
K241825Microwave Ablation AntennasNEY · Traditional Canyon Medical, Inc.09/20/2024SE
K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…NEY · Traditional Varian Medical Systems, Inc.07/19/2024SE
K240784Temperature Sensor Probe (ABL-18TP20)NEY · Traditional Varian Medical Systems, Inc.05/29/2024SE
K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…NEY · Special Medtronic, Inc.03/28/2024SE
K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)NEY · Traditional Hygea Medical Technology Co., Ltd.01/31/2024SE
K231738NEUWAVE™ Microwave Ablation System and AccessoriesNEY · Traditional Neuwave Medical, Inc.11/16/2023SE

More from Neuwave Medical, Inc.

510(k)DeviceDecision
K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)NEY · Traditional 08/08/2025SE
K222388swiftPro SystemNEY · Traditional 05/04/2023SE
K181941Swift SystemNEY · Traditional 10/18/2018SE

Questions and answers

When was swiftPro™ System cleared by the FDA?

swiftPro™ System (K240518) received a 510(k) decision of Substantially Equivalent on April 23, 2024, 60 days after the submission was received.

What is the product code of K240518?

The FDA product code is NEY – System, Ablation, Microwave And Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.