The following data is part of a premarket notification filed by Fujifilm New Development U.s.a., Inc. with the FDA for Fujifilm Surgical System.
| Device ID | K162836 |
| 510k Number | K162836 |
| Device Name: | FUJIFILM Surgical System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | FUJIFILM New Development U.S.A., Inc. 318 Bear Hill Road Waltham, MA 02451 |
| Contact | Stephen Mariano |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-11 |
| Decision Date | 2017-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856853006047 | K162836 | 000 |
| 00856853006030 | K162836 | 000 |
| 00856853006023 | K162836 | 000 |
| 00856853006016 | K162836 | 000 |