Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint
Summary
Medtronic, Inc. received 510(k) clearance for 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), a NEY device. Cleared on 2024-03-28.
Details
Source
510(k) Clearance
External ID
K233838
Action Date
2024-03-28
Status
Special
Category
device
Product Code
NEY
Product Description
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). Product code: NEY.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Medtronic, Inc. has received 37 total clearances in our database.
Medtronic, Inc. has 83 FDA actions in our database, including 46 recalls and 37 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Medtronic, Inc. have FDA actions?
Medtronic, Inc. has 83 FDA actions in our database, including 46 recalls and 37 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233838" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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