FDA.reportPublic FDA data

swiftPro URT Applicator Tip

Primary DI
05060652910107
Brand
swiftPro URT Applicator Tip
Company
EMBLATION LIMITED
Model
SWF-AT02-10
Catalog number
SWF-AT02-10
Device description
Box of Ten swiftPro URT Applicator Tips
Published
2023-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K222388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222388000swiftPro SystemEmblation , Ltd.2023-05-04NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060652910107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060652910107050606529101075060652910107

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative gamma radiation detection system probe coverA polymer sheath designed to cover an intraoperative gamma radiation detection system probe (not included) to create a physical barrier between the patient and the probe. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
211334261
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060652910176swiftPro Charging Dock DC Power AdaptorSWF-DCA02SWF-DCA022026-06-08
05060652910183Swift SystemSWF-SYSSWF-SYS2026-06-08
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
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
05060652910183Swift SystemEMBLATION 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