The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Dyonics 25 Fluid Management System.
| Device ID | K192155 |
| 510k Number | K192155 |
| Device Name: | Smith & Nephew DYONICS 25 Fluid Management System |
| Classification | Arthroscope |
| Applicant | Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Contact | Bryan Cowell |
| Correspondent | Bryan Cowell Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2019-09-04 |