DeviceClearance

Emprint Ablation System with Thermosphere Technology (Overall System Name) +9 more— 510(k) K233838

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K233838 for Emprint Ablation System with Thermosphere Technology (Overall System Name) +9 more, Substantially Equivalent on 2024-03-28. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Device name as filed
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.
Product code
Code NEY
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Lafayette, CO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NEY

product code NEY
Death
24
Injury
388
Malfunction
462
Other
1
Total
875

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.