The following data is part of a premarket notification filed by Novasys Medical, Inc. with the FDA for Novasys Transurethral Rf System.
| Device ID | K042132 |
| 510k Number | K042132 |
| Device Name: | NOVASYS TRANSURETHRAL RF SYSTEM |
| Classification | Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women |
| Applicant | NOVASYS MEDICAL, INC. 39684 EUREKA DR. Newark, CA 94560 |
| Contact | Debra Reisenthel |
| Correspondent | Debra Reisenthel NOVASYS MEDICAL, INC. 39684 EUREKA DR. Newark, CA 94560 |
| Product Code | NVJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-12-21 |