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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 a medical device manufactured by Emblation Limited. It received FDA 510(k) clearance on 2025-08-08 under approval 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. It is manufactured by Emblation Limited. The 510(k) number is K250718.

When was swiftPro System (SWF-SPS); Swift System (SWF-SYS) approved by the FDA?

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

What company makes swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

swiftPro System (SWF-SPS); Swift System (SWF-SYS) is manufactured by Emblation Limited.

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 Devices by Emblation Limited

K240518swiftPro™ System

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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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