These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type…
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
Who Else Makes It
Concentrated in Jiangsu (1), Beijing (1), Zhejiang (1).
Record
Regulatory record for Fujifilm Diathermic Slitter (FlushKnife) | Listed by | Fujifilm Corporation, Japan |
| FDA product code | KGE |
| Device type | Forceps, Biopsy, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2026-04-27 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 30 to 95 % RH; Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -10 to 45 °C; Handling environment humidity 30 to 85 % RH |
| Packaging | Box |
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.