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swiftPro System

by Emblation, Ltd.

510(k) K222388

swiftPro System is a medical device (FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Emblation, Ltd., cleared under FDA 510(k) K222388 on 4 May 2023, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222388 Date4 May 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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

Devices cleared under K222388

8 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 K222388
UDI-DISize and differences
swiftPro Cradle SWF-CRA01
Emblation Limited
SWF-CRA01 / SWF-CRA0105060652910084
Single use: no
On the market
swiftPro DC power adaptor SWF-DCA01
Emblation Limited
SWF-DCA01 / SWF-DCA0105060652910077
Single use: no
On the market
swiftPro Hand-Held Microwave Generator SWF-HAN01
Emblation Limited
SWF-HAN01 / SWF-HAN0105060652910060
Single use: no
On the market
swiftPro LRT Applicator Tip SWF-AT03
Emblation Limited
SWF-AT03 / SWF-AT0305060652910114
Single use: yes
On the market
swiftPro LRT Applicator Tip SWF-AT03-10
Emblation Limited
SWF-AT03-10 / SWF-AT03-1005060652910121
Single use: yes
On the market
swiftPro System SWF-MIC01
Emblation Limited
SWF-MIC01 / SWF-MIC0105060652910053
Single use: no
On the market
swiftPro URT Applicator Tip SWF-AT02
Emblation Limited
SWF-AT02 / SWF-AT0205060652910091
Single use: yes
On the market
swiftPro URT Applicator Tip SWF-AT02-10
Emblation Limited
SWF-AT02-10 / SWF-AT02-1005060652910107
Single use: yes
On the market

Similar devices

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

Other devices from Emblation, Ltd.

  • Swift System

    Class II

  • Swift®

    Class IIb

  • Swift®

    Class I

  • Swift®

    Class IIb

See all devices from Emblation, Ltd. →