Cleared Traditional

K240480 - IntelliBlate Microwave Ablation System Console (IB-CON) (FDA 510(k) Clearance)

Also includes:
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)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
36d slower than avg
Panel avg: 114d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K240480.
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
Temperature Sensor Probe (ABL-18TP20)
K240784 · Varian Medical Systems, Inc. · May 2024