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Swift System

by Emblation, Ltd.

510(k) K181941

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181941↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK181941 Date18 Oct 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181941 decided 18 Oct 2018 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
NEY
FDA applicant
Emblation , Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Swift System is a Microwave Ablation System and Accessories designed for targeted tissue treatment. It delivers controlled microwave energy to precisely ablate skin lesions, including verrucas and warts, without disrupting the surrounding skin surface. The device operates within the regulatory classification of Class II medical devices, adhering to standards for microwave ablation technology.

The system is intended for use in clinical settings by trained healthcare professionals. It is supplied as a reusable device with disposable accessories, ensuring sterility and single-use compliance for patient safety. The Swift System is authorised under FDA 510K and MDR, with a regulatory designation of Substantially Equivalent to predicate devices. Storage and handling follow manufacturer guidelines to maintain performance and sterility.

Devices cleared under K181941

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K181941
UDI-DISize and differences
Swift Applicator Handpiece SWF-HP01
Emblation Limited
SWF-HP01 / SWF-HP0105060652910022
Single use: no
On the market
Swift System SWF-SYS
Emblation Limited
SWF-SYS / SWF-SYS05060652910183
Single use: no
On the market
Swift® Applicator Tip SWF-ATO1
Emblation Limited
SWF-ATO1 / SWF-ATO105060652910039
Single use: yes
On the market
Swift® Applicator Tips SWF-AT01-10
Emblation Limited
SWF-AT01-10 / SWF-AT01-1005060652910046
Single use: yes
On the market
Swift® Interconnect Cable SWF-CA01
Emblation Limited
SWF-CA01 / SWF-CA0105060652910015
Single use: no
On the market
Swift® Microwave Generator SWF-GE01
Emblation Limited
SWF-GE01 / SWF-GE0105060652910008
Single use: no
On the market

Similar devices

Other devices filed under FDA product code NEY (System, Ablation, Microwave And Accessories).

Other devices from Emblation, Ltd.

  • swiftPro System

    Class II

  • Swift®

    Class IIb

  • Swift®

    Class I

  • Swift®

    Class IIb

See all devices from Emblation, Ltd. →