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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K233838
Device Name Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B)
Applicant
Medtronic, Inc.
200 Medtronic Dr.
Lafayette,  CO  80026
Applicant Contact Steve Pavlik
Correspondent
Medtronic, Inc.
200 Medtronic Dr.
Lafayette,  CO  80026
Correspondent Contact Steve Pavlik
Regulation Number878.4400
Classification Product Code
NEY  
Date Received12/04/2023
Decision Date 03/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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