The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Video Laparoscope.
| Device ID | K202130 |
| 510k Number | K202130 |
| Device Name: | FUJIFILM Video Laparoscope |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Fujifilm Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Kamila Sak Fujifilm Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-31 |
| Decision Date | 2020-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410438956 | K202130 | 000 |