Swift® Microwave Generator SWF-GE01

GUDID 05060652910008

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

EMBLATION LIMITED

Microwave hyperthermia system

• Primary Device ID: 05060652910008
• NIH Device Record Key: 0c367dc6-e248-4e5e-b83f-a5647f98f917
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swift® Microwave Generator
• Version Model Number: SWF-GE01
• Catalog Number: SWF-GE01
• Company DUNS: 211334261
• Company Name: EMBLATION LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060652910008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181941

FDA Product Code

• NEY: System, Ablation, Microwave And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-02

Devices Manufactured by EMBLATION LIMITED

• 05060652910053 - swiftPro System: 2023-12-12 swiftPro System
• 05060652910060 - swiftPro Hand-Held Microwave Generator: 2023-12-12 The swiftPro Hand-Held microwave generator is intended to be used with the swiftPro applicator tip for the coagulation of soft t
• 05060652910077 - swiftPro DC power adaptor: 2023-12-12 The swiftPro DC power adaptor is used to power the swiftPro hand-held generator
• 05060652910084 - swiftPro Cradle: 2023-12-12 The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use.
• 05060652910091 - swiftPro URT Applicator Tip: 2023-12-12 The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handp
• 05060652910107 - swiftPro URT Applicator Tip: 2023-12-12 Box of Ten swiftPro URT Applicator Tips
• 05060652910114 - swiftPro LRT Applicator Tip: 2023-12-12 The swiftPro LRT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handp
• 05060652910121 - swiftPro LRT Applicator Tip: 2023-12-12 Box of Ten swiftPro LRT Applicator Tips