The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Video Laparoscope, Video Processor, Light Source.
| Device ID | K192918 |
| 510k Number | K192918 |
| Device Name: | Video Laparoscope, Video Processor, Light Source |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 2588538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | GCJ |
| Subsequent Product Code | FET |
| Subsequent Product Code | NTN |
| Subsequent Product Code | NWB |
| Subsequent Product Code | PEA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2020-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14547410420682 | K192918 | 000 |