IntelliBlate Ximitry Probe Assembly, 13g X 15cm
The IntelliBlate Ximitry Probe Assembly delivers microwave energy for coagulation, or ablation, of soft tissue with the IntelliBlate Microwave Ablation System. It is a sterile, single-use…
The IntelliBlate Ximitry Probe Assembly delivers microwave energy for coagulation, or ablation, of soft tissue with the IntelliBlate Microwave Ablation System. It is a sterile, single-use assembly and is not intended for cardiac procedures. This listed probe is 13 gauge and 15 cm long.
Microwave energy heats target tissue by agitating water molecules, producing coagulation necrosis. The assembly includes the ablation probe, power cable, coolant tubing and a cassette for a closed cooling circuit. The cable connects directly to the system console.
Listed Item
IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G/15cm Probe QTY 1
Cooling Circuit
The console’s integrated peristaltic pump circulates coolant through the probe assembly. A single cable bundle combines the power cable with coolant supply and return lines.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Betters(Suzhou) Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
| Nanjing Devin Medical Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| ECO Medical Technology (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| Mima-PRO (NAN Tong) Scientific Inc. | Nantong | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Varian Medical Systems, Inc, United States |
|---|---|
| FDA product code | NEY |
| Device type | System, Ablation, Microwave And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K240480 |
| Record published | 2024-08-09 |
| Record revised | 2025-10-06 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 3, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IB-XPA-1315 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microwave Ablation Antennas | Canyon Medical Inc. | 66 |
| Neuwave | Neuwave Medical, Inc. | 25 |
| ECO Disposable microwave therapeutic antenna | ECO Medical Technology (Nanjing) Co., Ltd. | 21 |
| Hygea | Hygea Medical Technology Co., Ltd. | 18 |
| Avecure | MedWaves, Inc | 17 |
| Certus® 140 | Neuwave Medical, Inc. | 17 |
| Emprint | Covidien LP | 14 |
| Betters (Suzhou)Medical Co., Ltd. | Betters(Suzhou) Medical Co., Ltd. | 11 |
| Emprint SX | Covidien LP | 11 |
| Mima-Pro | Mima-PRO (NAN Tong) Scientific Inc. | 10 |
| Dophi | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 9 |
| Evident | Covidien LP | 8 |
Showing 12 of 55. All products under System, Ablation, Microwave And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240480 | 2024-07-19 |
| K240784 | 2024-05-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.