Cleared Traditional

Temperature Sensor Probe (ABL-18TP20)

K240784 · Varian Medical Systems, Inc. · General & Plastic Surgery
May 2024
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K240784 is an FDA 510(k) clearance for the Temperature Sensor Probe (ABL-18TP20), a System, Ablation, Microwave And Accessories (Class II — Special Controls, product code NEY), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 29, 2024, 69 days after receiving the submission on March 21, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K240784 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2024
Decision Date May 29, 2024
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code NEY — System, Ablation, Microwave And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400

Similar Devices — NEY System, Ablation, Microwave And Accessories

All 67
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); Swift System (SWF-SYS)
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); 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 · Varian Medical Systems, Inc. · Jul 2024