FDA.reportPublic FDA data

Swift Applicator Handpiece

Primary DI
05060652910022
Brand
Swift Applicator Handpiece
Company
EMBLATION LIMITED
Model
SWF-HP01
Catalog number
SWF-HP01
Device description
The Swift® applicator handpiece connects to the Swift® microwave generator via the Swift® interconnect cable.
Published
2019-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NEYSystem, Ablation, Microwave And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181941000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181941000Swift SystemEmblation , Ltd.2018-10-18NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060652910022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060652910022050606529100225060652910022

GMDN Terms#

Term, Definition table
TermDefinition
Microwave hyperthermia system applicator, extracorporealA component of a microwave hyperthermia system designed to direct and deliver microwave energy used to produce a systemic or local heating effect. It is typically mounted on a floor, wall, or ceiling suspension that allows the operator to position the microwave source from a point outside the patient's body. The applicator assembly includes cables and connectors that interface with the energy-generating unit of the hyperthermia system during treatments. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
211334261
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060652910053swiftPro SystemSWF-MIC01SWF-MIC012023-12-04
05060652910138swiftPro Battery PackSWF-BAT01SWF-BAT012024-06-26
05060652910145swiftPro Charging DockSWF-CHG01SWF-CHG012024-06-26
05060652910152swiftPro Battery Power SystemSWF-BPS01SWF-BPS012024-06-26
05060652910060swiftPro Hand-Held Microwave GeneratorSWF-HAN01SWF-HAN012023-12-04
05060652910077swiftPro DC power adaptorSWF-DCA01SWF-DCA012023-12-04
05060652910084swiftPro CradleSWF-CRA01SWF-CRA012023-12-04
05060652910091swiftPro URT Applicator TipSWF-AT02SWF-AT022023-12-04
05060652910107swiftPro URT Applicator TipSWF-AT02-10SWF-AT02-102023-12-04
05060652910114swiftPro LRT Applicator TipSWF-AT03SWF-AT032023-12-04
05060652910121swiftPro LRT Applicator TipSWF-AT03-10SWF-AT03-102023-12-04
05060652910008Swift® Microwave GeneratorSWF-GE01SWF-GE012019-01-02
05060652910015Swift® Interconnect CableSWF-CA01SWF-CA012019-01-02
05060652910039Swift® Applicator TipSWF-ATO1SWF-ATO12019-01-17
05060652910046Swift® Applicator TipsSWF-AT01-10SWF-AT01-102019-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06935650626468HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
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