The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Diathermic Slitter (flushknife).
| Device ID | K171096 |
| 510k Number | K171096 |
| Device Name: | Fujifilm Diathermic Slitter (FlushKnife) |
| Classification | Forceps, Biopsy, Electric |
| Applicant | FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Contact | Jeffrey Wan |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-13 |
| Decision Date | 2017-05-09 |
| Summary: | summary |