The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Synergy Rf System.
| Device ID | K161581 |
| 510k Number | K161581 |
| Device Name: | Arthrex Synergy RF System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHREX, INC. 1370 Creekside Blvd Naples, FL 34108 -1945 |
| Contact | William Heard |
| Correspondent | William Heard ARTHREX, INC. 1370 Creekside Blvd Naples, FL 34108 -1945 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-08 |
| Decision Date | 2016-09-09 |
| Summary: | summary |