FDA.reportPublic FDA data

Swift System

Primary DI
05060652910183
Brand
Swift System
Company
EMBLATION LIMITED
Model
SWF-SYS
Catalog number
SWF-SYS
Device description
Swift Generator, Handpiece and Cable.
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K250718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181941000Swift SystemEmblation , Ltd.2018-10-18NEY
K250718000swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited2025-08-08NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060652910183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060652910183050606529101835060652910183

GMDN Terms#

Term, Definition table
TermDefinition
Microwave hyperthermia systemA mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.

Regulatory Flags#

DUNS number
211334261
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060652910176swiftPro Charging Dock DC Power AdaptorSWF-DCA02SWF-DCA022026-06-08
05060652910213swiftPro SystemSWF-SPS01SWF-SPS012026-06-08
05060652910251SwiftipsSWF-AT02-LowSWF-AT02-Low2026-06-08
05060652910268SwiftipsSWF-AT02-MedSWF-AT02-Med2026-06-08
05060652910275SwiftipsSWF-AT02-HighSWF-AT02-High2026-06-08
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
05060652910022Swift Applicator HandpieceSWF-HP01SWF-HP012019-01-02
05060652910039Swift® Applicator TipSWF-ATO1SWF-ATO12019-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060652910176swiftPro Charging Dock DC Power AdaptorEMBLATION LIMITEDNEY2026-06-08
05060652910213swiftPro SystemEMBLATION LIMITEDNEY2026-06-08
05060652910251SwiftipsEMBLATION LIMITEDNEY2026-06-08
05060652910268SwiftipsEMBLATION LIMITEDNEY2026-06-08
05060652910275SwiftipsEMBLATION LIMITEDNEY2026-06-08
06935650621319HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621333HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621357HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621371HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622613HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622620HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622637HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622651HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622668HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622682HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622699HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622729HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623344HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623351HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650624327HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626048HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626451HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626468HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
05060359560971MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
05060359560490MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
06954414601015Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601022Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601039Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601046Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601053Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14