Swift System

FDA 510(k) K181941 · Emblation , Ltd.

Substantially Equivalent

510(k) numberK181941

Submission

Device name
Swift System
Applicant
Emblation , Ltd.
Alloa, GB
Received
July 20, 2018
Decision date
October 18, 2018
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

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More from Hygea Medical Technology Co., Ltd.

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

Questions and answers

When was Swift System cleared by the FDA?

Swift System (K181941) received a 510(k) decision of Substantially Equivalent on October 18, 2018, 90 days after the submission was received.

What is the product code of K181941?

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