The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujifilm Diathermic Slitter (flushknife), Diathermic Slitter (clutchcutter).
| Device ID | K151474 |
| 510k Number | K151474 |
| Device Name: | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) |
| Classification | Forceps, Biopsy, Electric |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Contact | Mary Moore |
| Correspondent | Mary Moore FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2016-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410334999 | K151474 | 000 |
| 04547410334500 | K151474 | 000 |
| 04547410334517 | K151474 | 000 |
| 04547410334524 | K151474 | 000 |
| 04547410334531 | K151474 | 000 |
| 04547410334548 | K151474 | 000 |
| 04547410334555 | K151474 | 000 |
| 04547410334562 | K151474 | 000 |
| 04547410334579 | K151474 | 000 |
| 04547410334586 | K151474 | 000 |
| 04547410334593 | K151474 | 000 |
| 04547410334609 | K151474 | 000 |
| 04547410334616 | K151474 | 000 |
| 04547410334982 | K151474 | 000 |
| 04547410334494 | K151474 | 000 |