Cleared Special

K233838 - Emprint Ablation System with Thermosphere Technology (Overall System Name)

Also marketed or referenced as:
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)

K233838 is an FDA 510(k) clearance for Emprint Ablation System with Thermosphe..., manufactured by Medtronic, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Special 510(k) pathway after a 115-day FDA review.

K233838 · Medtronic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K233838

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
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Modification to existing cleared device.

NEY Device Classification - Class 2, Special Controls

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 68
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K233838.
IntelliBlate Microwave Ablation System Console (IB-CON)
K240480 · Varian Medical Systems, Inc. · Jul 2024
Temperature Sensor Probe (ABL-18TP20)
K240784 · Varian Medical Systems, Inc. · May 2024
swiftPro™ System
K240518 · Emblation Limited · Apr 2024
Microwave Ablation Device (Exceed S10U)
K233140 · Hygea Medical Technology Co., Ltd. · Jan 2024
NEUWAVE™ Microwave Ablation System and Accessories
K231738 · Neuwave Medical, Inc. · Nov 2023
Microwave Ablation System (BD-GT)
K232240 · Betters(Suzhou) Medical Co., Ltd. · Nov 2023
K233838 · Emprint Ablation System with Thermosphere Technology (Overall System Name)
Download PDF FDA Summary Medtronic, Inc.