MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system. It enables ablation of potential malignant lesions such as…
MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system. It enables ablation of potential malignant lesions such as nodules or tumors. MicroBlate Fine, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (1).
Record
Regulatory record for MicroBlate Fine | Listed by | Creo Medical Ltd, United Kingdom |
| FDA product code | NEY |
| Device type | System, Ablation, Microwave And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K221672 |
| Record published | 2025-05-05 |
Specifications
Specifications | MRI safety | MR Unsafe |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 10 to 30 °C; Handling environment humidity 20 to 90 % RH; Handling environment atmospheric pressure 69 to 106 KiloPascal; Storage environment atmospheric pressure 69 to 109 KiloPascal; Storage environment humidity 20 to 90 % RH; Storage environment temperature 10 to 30 °C |
| Packaging | Carton, shipper 5-up of 5 |
| Sizes | Length 1.9 m; outer diameter 2.4 mm |
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.