The following data is part of a premarket notification filed by Surx, Inc. with the FDA for Surx Rf System.
| Device ID | K020952 |
| 510k Number | K020952 |
| Device Name: | SURX RF SYSTEM |
| Classification | Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue |
| Applicant | SURX, INC. 2675 COLLIER CANYON RD. Livermore, CA 94550 |
| Contact | Alan Curtis |
| Correspondent | Alan Curtis SURX, INC. 2675 COLLIER CANYON RD. Livermore, CA 94550 |
| Product Code | MUK |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-25 |
| Decision Date | 2002-05-30 |
| Summary: | summary |