EMBLATION LIMITED

Address:Forrester Lodge,Alloa Clackmannanshire,GB

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Ablation, Microwave And Accessories (NEY) (5)

Premarket Exempt

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Swift® Microwave Generator - 05060652910008 Catalog Number : SWF-GE01

Device Description : The Swift® microwave generator is intended to be used with the Swift® applicator The Swift® microwave generator is intended to be used with the Swift® applicator for the coagulation of soft tissue.

Device Class : 2

Duns Number: 211334261

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

Swift® Interconnect Cable - 05060652910015 Catalog Number : SWF-CA01

Device Description : The Swift® interconnect cable connects the Swift® handpiece with the Swift® micr The Swift® interconnect cable connects the Swift® handpiece with the Swift® microwave generator.

Device Class : 2

Duns Number: 211334261

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

Swift Applicator Handpiece - 05060652910022 Catalog Number : SWF-HP01

Device Description : The Swift® applicator handpiece connects to the Swift® microwave generator via t The Swift® applicator handpiece connects to the Swift® microwave generator via the Swift® interconnect cable.

Device Class : 2

Duns Number: 211334261

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

Swift® Applicator Tip - 05060652910039 Catalog Number : SWF-ATO1

Device Description : Swift® applicator tip is provided as a single-use, non-sterile disposable tip, w Swift® applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.

Device Class : 2

Duns Number: 211334261

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

Swift® Applicator Tips - 05060652910046 Catalog Number : SWF-AT01-10

Device Description : Box of Ten Swift® applicator tips. Swift® applicator tip is provided as a singl Box of Ten Swift® applicator tips. Swift® applicator tip is provided as a single use, non-sterile disposable tip, which is connected to the Swift® handpiece.

Device Class : 2

Duns Number: 211334261

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

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