IntelliBlate Ximitry Probe Assembly, 13g X 20cm
The IntelliBlate Ximitry Probe Assembly is the sterile, disposable treatment component used with the IntelliBlate Microwave Ablation System to coagulate soft tissue. This configuration has…
The IntelliBlate Ximitry Probe Assembly is the sterile, disposable treatment component used with the IntelliBlate Microwave Ablation System to coagulate soft tissue. This configuration has a 20-centimetre probe. It is not intended for cardiac procedures.
The probe connects to the separate microwave generator to deliver treatment energy. Its assembly includes coolant tubing and an integrated cassette that forms part of a closed cooling circuit. The generator’s peristaltic pump moves coolant through that circuit.
Listed Item
IntelliBlate Ximitry probe assembly includes cassette with saline tubing, Ximitry laser alignment disc, and microwave ablation probe 13G/20cm Probe QTY 1
Probe Components
The assembly includes a coolant spike and power cable. The probe has a ceramic trocar tip. Cooling can use sterile water or saline, and the assembly is intended for single use.
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IB-XPA-1320 | 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.