The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Opes Electrodes And Accessories.
| Device ID | K023986 |
| 510k Number | K023986 |
| Device Name: | ARTHREX OPES ELECTRODES AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Ann Waterhouse |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-12-02 |
| Decision Date | 2002-12-17 |
| Summary: | summary |