Cleared Special

K233838 - Emprint Ablation System with Thermosphere Technology (Overall System Name) (FDA 510(k) Clearance)

Also includes:
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)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233838 · Medtronic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
115d
Days
Class 2
Risk

K233838 is an FDA 510(k) clearance for the Emprint Ablation System with Thermosphere Technology (Overall System Name). Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Medtronic, Inc. (Lafayette, US). The FDA issued a Cleared decision on March 28, 2024 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K233838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2023
Decision Date March 28, 2024
Days to Decision 115 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 114d · This submission: 115d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEY System, Ablation, Microwave And Accessories

All 67
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K233838.
Microwave Ablation Device
K252632 · Nanjing Dewen Medical Technology Co., Ltd. · Mar 2026
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
K253771 · Nanjing Devin Medical Technology Co., Ltd. · Mar 2026
swiftPro System (SWF-SPS)
K250718 · Emblation Limited · Aug 2025
Microwave Ablation Generator (KY-2000A, KY-2100A)
K241827 · Canyon Medical, Inc. · Sep 2024
Microwave Ablation Antennas
K241825 · Canyon Medical, Inc. · Sep 2024
IntelliBlate Microwave Ablation System Console (IB-CON)
K240480 · Varian Medical Systems, Inc. · Jul 2024