The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Fms Vue Ii Fluid Management And Tissue Debridement System.
| Device ID | K171237 |
| 510k Number | K171237 |
| Device Name: | FMS VUE II Fluid Management And Tissue Debridement System |
| Classification | Arthroscope |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle Neuchatel, CH 2400 |
| Contact | Tatyana Korsunsky |
| Correspondent | Tatyana Korsunsky DePuy Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham, MA 02767 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-27 |
| Decision Date | 2018-01-18 |
| Summary: | summary |