The following data is part of a premarket notification filed by Surx, Inc. with the FDA for Surx Radiofrequency Electrosurgical Generator System And Accessories (surx Lp System).
| Device ID | K011190 |
| 510k Number | K011190 |
| Device Name: | SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) |
| Classification | Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue |
| Applicant | SURX, INC. 6900 KOLL CENTER PKWY., #417 Pleasanton, CA 94566 |
| Contact | Alan Curtis |
| Correspondent | Alan Curtis SURX, INC. 6900 KOLL CENTER PKWY., #417 Pleasanton, CA 94566 |
| Product Code | MUK |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2002-01-08 |