K233838

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)

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. CO · US
Product code: NEY — System, Ablation, Microwave And Accessories
Decision date: 2024-03-28
Date received: 2023-12-04
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General, Plastic Surgery

510(k) Summary (official FDA PDF): K233838.pdf

Official FDA record: K233838

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.