These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision,…
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
Who Else Makes It
Concentrated in Jiangsu (1), Beijing (1), Zhejiang (1).
Record
Regulatory record for Fujifilm | 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 |
| 510(k) | K220053 |
| Record published | 2022-03-04 |
| Record revised | 2024-06-06 (version 4) |
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 | Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| 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.