Cleared Traditional

K240480 - IntelliBlate Microwave Ablation System Console (IB-CON)

Also marketed or referenced as:
IntelliBlate Microwave Ablation System Mobile Cart (IB-CART) IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315) IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320) IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)

K240480 is an FDA 510(k) clearance for IntelliBlate Microwave Ablation System ..., manufactured by Varian Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K240480 · Varian Medical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
150d
Days
Class 2
Risk

K240480 is an FDA 510(k) clearance for the IntelliBlate Microwave Ablation System Console (IB-CON). Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 19, 2024 after a review of 150 days - an extended review cycle.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Varian Medical Systems, Inc. devices

FDA 510(k) Submission Details - K240480

510(k) Number K240480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2024
Decision Date July 19, 2024
Days to Decision 150 days
Submission Type Traditional
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
35d slower than avg
Panel avg: 115d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 50
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K240480.
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
Temperature Sensor Probe (ABL-18TP20)
K240784 · Varian Medical Systems, Inc. · May 2024
swiftPro™ System
K240518 · Emblation Limited · Apr 2024
Emprint Ablation System with Thermosphere Technology (Overall System Name)
K233838 · Medtronic, Inc. · Mar 2024