The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Diathermic Slitter (flushknife) Dk2620ji And Dk2623ji.
| Device ID | K220053 |
| 510k Number | K220053 |
| Device Name: | Diathermic Slitter (FlushKnife) DK2620JI And DK2623JI |
| Classification | Forceps, Biopsy, Electric |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Dhara Buch FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-06 |
| Decision Date | 2022-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410470543 | K220053 | 000 |
| 04547410470437 | K220053 | 000 |
| 14547410470441 | K220053 | 000 |
| 14547410470458 | K220053 | 000 |
| 14547410470465 | K220053 | 000 |
| 04547410470475 | K220053 | 000 |
| 14547410470489 | K220053 | 000 |
| 14547410470496 | K220053 | 000 |
| 14547410470502 | K220053 | 000 |
| 14547410470519 | K220053 | 000 |
| 14547410470526 | K220053 | 000 |
| 14547410470533 | K220053 | 000 |
| 04547410470420 | K220053 | 000 |