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), Fujifilm Diathermic Slitter (clutchcutter).
| Device ID | K161186 |
| 510k Number | K161186 |
| Device Name: | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) |
| Classification | Forceps, Biopsy, Electric |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Contact | Shraddha More |
| Correspondent | Shraddha More 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 | 2016-04-27 |
| Decision Date | 2016-06-29 |
| Summary: | summary |